MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS GN 18GA X 1.16IN PRN-CAP Y; CATHETER

Catalog Number 383952

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2020

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.

Event Description

It was reported that pegasus gn 18ga x 1.16in prn-cap y package was damaged.The following information was provided by the initial reporter: during daily routine inspection, the outer package of the closed needle puncture proof vein indwelling needle is found to be damaged, it was replaced immediately and reported to the equipment department.

Event Description

It was reported that pegasus gn 18ga x 1.16in prn-cap y package was damaged.The following information was provided by the initial reporter: during daily routine inspection, the outer package of the closed needle puncture proof vein indwelling needle is found to be damaged, it was replaced immediately and reported to the equipment department.

Manufacturer Narrative

H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.See h.10.

• Brand Name: PEGASUS GN 18GA X 1.16IN PRN-CAP Y
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 11152511
• MDR Text Key: 227110179
• Report Number: 3006948883-2021-00052
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: PENDING
• 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: 02/10/2021

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: Other
• Device Expiration Date: 05/12/2023
• Device Catalogue Number: 383952
• Device Lot Number: 0078906
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1