EPIDURAL CATHETERIZATION SET

Report

Report Number: 3006425876-2019-00967
Event Type: Malfunction
Date Received: December 11, 2019
Date of Event: July 1, 2019
Report Date: November 15, 2019
Manufacturer: ARROW INTERNATIONAL INC.
Product Code: CAZ
PMA / PMN Number: K103658
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 0

QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED, THE CURVATURE OF THE EPIDURAL NEEDLE (SPECTRA) FOR THE REPORTED KIT (UM-05400-B) IS DIFFERENT COMPARED TO A PAJUNK EPIDURAL NEEDLE. THE CUSTOMER ONE SEALED REPRESENTATIVE KIT FROM THE SAME LOT # AS REPORTED ON THE COMPLAINT (71F18G0582) FOR INVESTIGATION (REFERENCE FILES INP1900073599). THE ACTUAL COMPLAINT SAMPLE WAS NOT RECEIVED. THE RETURNED KIT WAS OPENED , AND THE EPIDURAL NEEDLE WAS REMOVED AND WAS VISUALLY EXAMINED. VISUAL EXAMINATION OF THE NEEDLE REVEALED THAT THE SYRINGE APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. THE RETURNED NEEDLE (SPECTRA) WAS COMPARED TO A PAJUNK NEEDLE (KZ-05400-006) USING AN OPTICAL COMPARATOR (10117770). BOTH NEEDLES HAVE THE SAME SPECIFICATIONS; HOWEVER, THE PAJUNK NEEDLE'S BEVEL HAS SLIGHTLY MORE CURVATURE COMPARED TO THE SPECTRA NEEDLE (REFERENCE FILES ANP1900073599). THE CUSTOMER ALSO PROVIDED PHOTOS COMPARING THE TWO NEEDLES. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED NEEDLE'S BEVEL. THE CURVATURE ANGLE FOR THE CANNULA WAS MEASURED TWICE USING THE OPTICAL COMPARATOR (10117770) WITH THE RESULTS OF 6.4DEG AND 6.9DEG RESPECTIVELY WHICH IS WITHIN THE SPECIFICATION OF 5DEG - 10DEG PER GRAPHIC RZ-05400-006; REV 01. ALSO, A DIMENSIONAL INSPECTION WAS PERFORMED ON THE HEEL OF THE CANNULA (10117770). THE HEEL MEASURED 0.127MM, WHICH IS WITHIN THE SPECIFICATION OF 0.0MM - 0.5MM PER GRAPHIC RZ-05400-006; REV 01. SPECIFICATIONS PER GRAPHIC RZ-05400-006, REV 01 WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # RZ-05400-006 AS A PART OF THIS COMPLAINT INVESTIGATION. THERE HAVE BEEN NO MATERIAL CHANGES FOR THIS PART DURING THE LAST TWO YEARS THAT COULD HAVE LED TO THIS COMPLAINT. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE COMPLAINT COULD NOT BE CONFIRMED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL COMPLAINT SAMPLE. THE REPRESENTATIVE SAMPLE RECEIVED WAS FUNCTIONALLY TESTED AND VISUALLY INSPECTED WITH NO ISSUE FOUND. THE REPORTED COMPLAINT OF THE CURVATURE FOR THE EPIDURAL NEEDLE FOR THE REPORTED KIT COMPARED TO A PAJUNK NEEDLE WAS DIFFERENT WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED; ONLY A REPRESENTATIVE SAMPLE WAS RECEIVED. ALTHOUGH, THE CURVATURE FOR BOTH NEEDLES WAS SLIGHTLY DIFFERENT WHEN COMPARED WITH EACH OTHER, THE RETURNED NEEDLE'S BEVEL WAS FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED ISSUE. A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED OR WITHOUT THE ACTUAL COMPLAINT SAMPLE.

Description of Event or Problem · 0

IT WAS REPORTED THAT SINCE APPROXIMATELY (B)(6)2019 , THE CUSTOMER HAS NOTICED THAT AFTER THE USE OF THE PDK SET, MORE PATIENTS WITH POST SPINAL HEADACHE ARE REPORTED. THIS IS SAID TO BE DUE TO PUNCTURE THROUGH THE DURA INTO THE SPINAL CANAL. THE CUSTOMER SUSPECTS THAT THIS IS DUE TO THE TUOHY NEEDLE OF THE SET. COMPARED TO THE PAJUNK TOUHY NEEDLE, THIS WOULD HAVE A STEEPER CUT AT THE TIP. THE PAJUNK CANNULA HAS A LARGER UPWARD CURVATURE. THE PUNCTURE SITE IS THE LUMBAR SPINE. SINCE ONE WEEK A SEPARATELY ORDERED TUOHY NEEDLE FROM PAJUNK PN 1150-4M090 IS USED FOR PUNCTURING. SINCE THEN THERE HAS BEEN A SIGNIFICANT IMPROVEMENT NOTED. IN THE FIRST HALF OF THE YEAR, (B)(4) CASES OF POST SPINAL HEADACHE WERE REPORTED. FROM JULY, (B)(4) 3 MONTHS LATER, AN INCREASE TO 30 HEADACHES WAS OBSERVED. THERE ARE DIFFERENT USERS AFFECTED USING OUR SYSTEM. FROM THE ASSISTANT PHYSICIAN OVER SPECIALIST UP TO EXPERIENCED SENIOR PHYSICIANS. APPROXIMATELY (B)(4) OCCURRENCES WERE REPORTED BY CUSTOMER. BASED ON THE ADDITIONAL INFORMATION AND DRAWINGS PROVIDED BY THE CUSTOMER THE REPORTED ISSUE IS THE DESIGN OF THE NEEDLE (LESS CURVING OF THE NEEDLE) LEADS TO ACCIDENTAL PUNCTURE OF THE CEREBROSPINAL FLUID SPACE.

Additional Manufacturer Narrative · 1

QN#: (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

Description of Event or Problem · 1

IT WAS REPORTED THAT SINCE APPROXIMATELY (B)(6) 2019, THE CUSTOMER HAS NOTICED THAT AFTER THE USE OF THE PDK SET, MORE PATIENTS WITH POST SPINAL HEADACHE ARE REPORTED. THIS IS SAID TO BE DUE TO PUNCTURE THROUGH THE DURA INTO THE SPINAL CANAL. THE CUSTOMER SUSPECTS THAT THIS IS DUE TO THE TUOHY NEEDLE OF THE SET. COMPARED TO THE PAJUNK TOUHY NEEDLE, THIS WOULD HAVE A STEEPER CUT AT THE TIP. THE PAJUNK CANNULA HAS A LARGER UPWARD CURVATURE. THE PUNCTURE SITE IS THE LUMBAR SPINE. SINCE ONE WEEK A SEPARATELY ORDERED TUOHY NEEDLE FROM PAJUNK PN 1150-4M090 IS USED FOR PUNCTURING. SINCE THEN THERE HAS BEEN A SIGNIFICANT IMPROVEMENT NOTED. IN THE FIRST HALF OF THE YEAR, 5 CASES OF POST SPINAL HEADACHE WERE REPORTED. FROM (B)(6), 3 MONTHS LATER, AN INCREASE TO 30 HEADACHES WAS OBSERVED. THERE ARE DIFFERENT USERS AFFECTED USING OUR SYSTEM. FROM THE ASSISTANT PHYSICIAN OVER SPECIALIST UP TO EXPERIENCED SENIOR PHYSICIANS. APPROXIMATELY 40 OCCURRENCES WERE REPORTED BY CUSTOMER. BASED ON THE ADDITIONAL INFORMATION AND DRAWINGS PROVIDED BY THE CUSTOMER THE REPORTED ISSUE IS THE DESIGN OF THE NEEDLE (LESS CURVING OF THE NEEDLE) LEADS TO ACCIDENTAL PUNCTURE OF THE CEREBROSPINAL FLUID SPACE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1249158	EPIDURAL CATHETERIZATION SET	ANESTHESIA CONDUCTION KIT	CAZ	ARROW INTERNATIONAL INC.	IPN046734	71F18G0582

Patients

Seq	Age	Sex	Outcome	Treatment
1