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

Catalog Number 388638

Device Problem Fitting Problem (2183)

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

Event Date 10/07/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 bd 9086633 - prn adapter-388638-cap loose the following information was provided by the initial reporter; on october 7, the nurse replaced the heparin cap while maintaining the patient's picc tube.After replacing the heparin cap, the heparin cap could not be tightened and fell off on its own.The heparin cap was immediately replaced with a new one.

Manufacturer Narrative

1.No sample was returned, and no defective picture was returned.2.Review batch record information, 1) the complaint lot#2263541 was produced in the prn automatic assembly line, the production date is 2022-11, and the m860 packaging machine was packaged in 2022-11, and the batch of products totaled (b)(4); 2) check the process inspection and shipment inspection report of this batch of products.The test results meet the product standards and there is no abnormality.3) check the production records and machine maintenance of this batch of products, and there are no abnormalities, deviations or rework activities.3.Checked the retained sample performed the leakage test on the retained sample, the test rational: rotate the prn of the retained sample on the standard lure connector, inject the standard water pressure, after continuing for the standard time, prn should no leakage.Test result: no abnormality was observed after test completed, attachment 1- test report of the retained sample.4.Root cause cannot be confirmed.Plant continues pay attention to this defect.H3 other text : see narrative.

Event Description

No additional information provided.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18120719
• MDR Text Key: 328147972
• Report Number: 3014704491-2023-00731
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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: 2263541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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