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

Catalog Number 388638

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 08/29/2023

Event Type  malfunction  

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.

Event Description

It was reported that the bd¿ prn adapter heparin cap fell off after the infusion and leaked out blood onto the sheets.The following information was provided by the initial reporter, translated from chinese: "the patient epigastric pain for more than 2 days and was admitted to the hospital on (b)(6) 2023, where she was treated with indwelling needle infusion, and the catheter was sealed with heparin cap once after infusion.On (b)(6) 2023, the nurse found blood on the sheet during night visit, and the examination found that the heparin cap had fallen off, resulting in the venous blood of about 10ml flowing from the indwelling needle.The patient's family requested to review the blood routine, but the indentation needle could not be used, so the indentation needle was pulled out again, the indentation needle was replaced again, and a new heparin cap was replaced, which caused secondary damage to the patient.".

Event Description

It was reported that the bd¿ prn adapter heparin cap fell off after the infusion and leaked out blood onto the sheets.The following information was provided by the initial reporter, translated from chinese: "the patient epigastric pain for more than 2 days and was admitted to the hospital on (b)(6) 2023, where she was treated with indwelling needle infusion, and the catheter was sealed with heparin cap once after infusion.On (b)(6) 2023, the nurse found blood on the sheet during night visit, and the examination found that the heparin cap had fallen off, resulting in the venous blood of about 10ml flowing from the indwelling needle.The patient's family requested to review the blood routine, but the indentation needle could not be used, so the indentation needle was pulled out again, the indentation needle was replaced again, and a new heparin cap was replaced, which caused secondary damage to the patient.".

Manufacturer Narrative

H6: investigation summary: a device history review was conducted for lot number 2222242.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, 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.

• 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: 17814189
• MDR Text Key: 324614730
• Report Number: 3014704491-2023-00595
• 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: Other
• Device Catalogue Number: 388638
• Device Lot Number: 2222242
• Was Device Available for Evaluation?: No
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1