MAUDE Adverse Event Report: BD (SUZHOU) PRN ADAPTER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 388638

Device Problem Unsealed Device Packaging (1444)

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

Event Date 05/12/2021

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 prn adapter had hair inside the package.The following information was provided by the initial reporter: there was hair inside the package.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 0322592.Our records show that this is the only instance of foreign matter 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.Additionally the photo submitted by the facility was reviewed by our quality engineers, who determined that the identity of the foreign matter was hair from the clothing of one of our operators.The most likely root cause for this is related to inappropriate use of the proper protective equipment.H3 other text : see h.10.

Event Description

It was reported that prn adapter had hair inside the package.The following information was provided by the initial reporter: there was hair inside the package.

• Brand Name: PRN ADAPTER
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 12006105
• MDR Text Key: 267140045
• Report Number: 3006948883-2021-00690
• Device Sequence Number: 1
• Product Code: FPA
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 388638
• Device Lot Number: 0322592
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1