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

Catalog Number 388638

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported that the bd¿ prn adapter packaging was found damaged.The following information was provided by the initial reporter, translated from chinese: "the patient was admitted to the hospital on (b)(6) 2022.He needed intravenous infusion and an indwelling needle.After the infusion, he needed to seal the tube head with a prn.It was found that the outer packaging of the prn was damaged.Replace with new one.".

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 the bd¿ prn adapter packaging was found damaged.The following information was provided by the initial reporter, translated from chinese: "the patient was admitted to the hospital on (b)(6) 2022.He needed intravenous infusion and an indwelling needle.After the infusion, he needed to seal the tube head with a prn.It was found that the outer packaging of the prn was damaged.Replace with new one.".

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 1257125.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 sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD¿ PRN ADAPTER
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16164317
• MDR Text Key: 308179347
• Report Number: 3014704491-2022-00744
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2023

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 Catalogue Number: 388638
• Device Lot Number: 1257125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/22/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1