FDA Adverse Event Malfunction Summary report: N

3006948883-2019-00166

MDR report key: 8404515 · Received March 8, 2019

Report

Report Number: 3006948883-2019-00166
Event Type: Malfunction
Date Received: March 8, 2019
Date of Event: February 20, 2019
Report Date: April 10, 2019
PMA / PMN Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 6173461. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF A MISSING HEPARIN CAP OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. AFTER REVIEWING THE DEVICE SUBMITTED OUR QUALITY ENGINEERS DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS HUMAN ERROR. DURING ASSEMBLY IT IS POSSIBLE FOR THE CAP TO NOT BE COMPLETELY SECURED, DURING THE SUBSEQUENT TRANSFER TO THE PACKAGING STATION THE CAP CAN BECOME DISLODGED. TO PREVENT A FUTURE OCCURRENCE OF THIS ISSUE, WE HAVE RETRAINED OUR MANUFACTURING, PACKAGING, ND INSPECTION PERSONNEL ON THE PROPER PROCEDURES.

Description of Event or Problem · 0

IT WAS REPORTED THAT BEFORE USE OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THE CAP WAS MISSING. IT'S BEEN NOTICED THAT THE PRN WAS MISSING WHEN UNPACKED.

Additional Manufacturer Narrative · 1

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT BEFORE USE OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THE CAP WAS MISSING. IT'S BEEN NOTICED THAT THE PRN WAS MISSING WHEN UNPACKED.

Patients

Seq	Age	Sex	Outcome	Treatment
0			Other