MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383712

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the package of 4 bd pegasus¿ safety closed iv catheter system was damaged.The following was translated from chinese to english: the teacher from the general affairs department opened the package and found that the indwelling needle package was covered with black tape.He returned it to the salesperson.After the salesperson tore off the black tape, he found that the package was damaged and could not be used clinically.

Event Description

The teacher from the general affairs department opened the package and found that the indwelling needle package was covered with black tape.He returned it to the salesperson.After the salesperson tore off the black tape, he found that the package was damaged and could not be used clinically.

Manufacturer Narrative

There was a visual inspection to check for fm during outgoing inspection as per mqa-069/c.There was no fm qn raised for fm on this batch.1 photo is received.Refer to attachment a.A black tape was observed on the top web of the pegasus units.4 samples were received.Refer to attachment b.A black tape was observed on the top web of the 4 pegasus units.The black tape is from the raw material top web use to splice 2 top webs together in a roll.There is a sensor online in the pegasus line to detect any tape during production.The machine will stop when there is a tape detected.There was no faulty sensor during the production of this batch.The possible cause of the tape on the 4 returned units could likely be the pt cutting and re-joining the top web material after the sensor causing the top web not detected by the sensor after the re-joining.The complaint trend will be tracked and monitored.Description of the proposed action: 1 procedure 70005725 to update an instruction to cut and re-join top web before the sensor.(assigned to peter ng boon siong, target completion date : 15-dec-2023) effectiveness check pan: 1 perform 3 random check on pt are re-joining the top web before the sensor.Monitoring period: 8 weeks after implementation acceptance criteria: zero non-conformity (assigned to pang kok hong, target completion date : 09-feb-2023).

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17839576
• MDR Text Key: 324575728
• Report Number: 8041187-2023-00514
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383712
• Device Lot Number: 2291079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1