MAUDE Adverse Event Report: BD (SUZHOU) PRN ADAPTER

Catalog Number 388638

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

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 foreign matter was found before use with a prn adapter.The following information was provided by the initial reporter, "on (b)(6) 2019, when preparing to change the cvc heparin cap of the patient's, it was found that the unopened prn contained a black foreign matter, so the use of this consumable material was stopped.The hospital also checked the same batch of products.".

Event Description

It was reported that foreign matter was found before use with a prn adapter.The following information was provided by the initial reporter, "on (b)(6) 2019, when preparing to change the cvc heparin cap of the patient's , it was found that the unopened prn contained a black foreign matter, so the use of this consumable material was stopped.The hospital also checked the same batch of products.".

Manufacturer Narrative

H.6.Investigation summary a device history review was conducted for lot number 9018775.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.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.

• Brand Name: PRN ADAPTER
• Type of Device: ADAPTER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9566597
• MDR Text Key: 180718210
• Report Number: 3006948883-2019-01187
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 388638
• Device Lot Number: 9018775
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other