MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD¿ PEGASUS YEL 24GA X 0.75IN PRN; CATHETER

Catalog Number 383911

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2019

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 has been reported that one bd¿ pegasus yel 24ga x 0.75in prn has been found experiencing sterility issues before use.The following has been provided by the initial reporter: it's noticed that needle cap missing and result in needle stick before use.

Event Description

It has been reported that one bd¿ pegasus yel 24ga x 0.75in prn has been found experiencing sterility issues before use.The following has been provided by the initial reporter: it's noticed that needle cap missing and result in needle stick before use.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 8302651.Our records show that this is the only instance of this issue 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.A review of the manufacturing process was able to determine that the most likely root cause for this event is related to the transfer of manufactured goods to the packaging station.During this activity the shield may become dislodged.Occurrences such as these are closely monitored by finished goods inspections; in response to this occurrence we have retrained the responsible personnel.

• Brand Name: BD¿ PEGASUS YEL 24GA X 0.75IN PRN
• Type of Device: CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9458875
• MDR Text Key: 179321001
• Report Number: 3006948883-2019-01077
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/10/2021
• Device Catalogue Number: 383911
• Device Lot Number: 8302651
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other