MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) PEGASUS YEL 24GA X 0.75IN QSYTE-CAP Y; INTRAVASCULAR CATHETER

Catalog Number 383714

Device Problem Volume Accuracy Problem (1675)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a pegasus yel 24ga x 0.75in qsyte-cap y had a damaged connector at an unspecified time.The following was reported by the initial reporter: "when package was opened, it was found that the joint was cracked and damaged.Google translation: when fei q was disassembled, it was found that the q plug connector was cracked and damaged.The batch complained about two cases of joints falling off on monday, and on wednesday, the gastroenterology department complained that the joints were broken when they were disassembled.

Event Description

It was reported that a pegasus yel 24ga x 0.75in qsyte-cap y had a damaged connector at an unspecified time.The following was reported by the initial reporter: "when package was opened, it was found that the joint was cracked and damaged google translation when fei q was disassembled, it was found that the q plug connector was cracked and damaged.The batch complained about two cases of joints falling off on monday, and on wednesday, the gastroenterology department complained that the joints were broken when they were disassembled.".

Manufacturer Narrative

H6: investigation summary a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 0055001, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the q-syte connector has damage to the top body and septum.Based off the provided photo the engineer was able to verify the reported defect.It was determined that during the q-syte manufacturing process the observed damage may have been caused during the onloading, adhesive, and offloading processes.This would be due to a misalignment between the part and the grippers.H3 other text : see h10.

• Brand Name: PEGASUS YEL 24GA X 0.75IN QSYTE-CAP Y
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11061847
• MDR Text Key: 223606636
• Report Number: 8041187-2020-00868
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 383714
• Device Lot Number: 0055001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1