BD¿ CATHETER TIP SYRINGE
Report
- Report Number
- 1911916-2022-00544
- Event Type
- Malfunction
- Date Received
- September 30, 2022
- Date of Event
- September 7, 2022
- Report Date
- February 22, 2023
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- KYZ
- UDI-DI
- 00382903096206
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER E-MAIL: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY IT WAS REPORTED THE SYRINGE WAS TOO TIGHT. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE IN ITS PACKAGING BLISTER. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309620, LOT NUMBER 0062250. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 21FEB2023. H6. INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE WAS TOO TIGHT. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN TESTED FOR SUSTAINING FORCE, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, PER IT16 AND THE RESULT WAS WITHIN SPECIFICATION. THE PHOTO SHOWS A SYRINGE IN ITS PACKAGING BLISTER. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309620, LOT NUMBER 0062250. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
IT WAS REPORTED THAT THE BD¿ CATHETER TIP SYRINGE PLUNGER WAS TIGHT AND DIFFICULT TO MOVE DURING THE NASAL GASTRIC ASPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE IS TOO TIGHT. CUSTOMER COMPLAINT DIFFICULTY TO DO NASAL GASTRIC TUBE ASPIRATION.
IT WAS REPORTED THAT THE BD¿ CATHETER TIP SYRINGE PLUNGER WAS TIGHT AND DIFFICULT TO MOVE DURING THE NASAL GASTRIC ASPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE IS TOO TIGHT. CUSTOMER COMPLAINT DIFFICULTY TO DO NASAL GASTRIC TUBE ASPIRATION."
IT WAS REPORTED THAT THE BD¿ CATHETER TIP SYRINGE PLUNGER WAS TIGHT AND DIFFICULT TO MOVE DURING THE NASAL GASTRIC ASPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE IS TOO TIGHT. CUSTOMER COMPLAINT DIFFICULTY TO DO NASAL GASTRIC TUBE ASPIRATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2170358 | BD¿ CATHETER TIP SYRINGE | IRRIGATING SYRINGE | KYZ | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 0062250 | 00382903096206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |