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

Catalog Number 388638

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported that the bd¿ prn adapter heparin cap was loose and fell off during the infusion.The following information was provided by the initial reporter, translated from chinese: "the patient was admitted to the hospital for further surgical treatment on (b)(6) 2023 after admission and was given intravenous infusion with indwelling needle.After infusion, the catheter was sealed with heparin cap once.The nurse's examination on the next day, from (b)(6) 2023, found that the one-time heparin cap had fallen off and the indwelling needle could not be used, so the indwelling needle was re-punctured and replaced.Replacing disposable heparin caps to seal tubes causes secondary harm to patients.".

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 2222242.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, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h10.

Event Description

It was reported that the bd¿ prn adapter heparin cap was loose and fell off during the infusion.The following information was provided by the initial reporter, translated from chinese: "the patient was admitted to the hospital for further surgical treatment on (b)(6) 2023 after admission and was given intravenous infusion with indwelling needle.After infusion, the catheter was sealed with heparin cap once.The nurse's examination on the next day, from 2023-08, found that the one-time heparin cap had fallen off and the indwelling needle could not be used, so the indwelling needle was re-punctured and replaced.Replacing disposable heparin caps to seal tubes causes secondary harm to patients.".

• Brand Name: BD¿ PRN ADAPTER
• Type of Device: INTRAVASCULAR CATHETER
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17814188
• MDR Text Key: 324266592
• Report Number: 3014704491-2023-00594
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 10/22/2023

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: Health Professional
• Device Catalogue Number: 388638
• Device Lot Number: 2222242
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 10/22/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1