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

Catalog Number 388638

Device Problem Break (1069)

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

Event Date 11/01/2023

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 prn adapter adaptor/connector is defective /damaged the following information was provided by the initial reporter; interventional surgery center to the hepatic artery angiography hepatic artery cannulation, to the heparin cap and tubing back to the hospital area micropump maintenance to continue to hit the drug, hit the drug on the way to the heparin cap burst, the rubber directly with the main body separation.

Event Description

No additional information provided.

Manufacturer Narrative

1.No sample were returned; 2.Review batch record information, 1) the complaint lot#2286528 was produced in the prn automatic assembly line, the production date is 2022-12, and the m860 packaging machine was packaged in 2022-12, and the batch of products totaled 439.6k; 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.Perform the function test on the retained sample of the complaint lot: 1) pull force test.2) leakage test.The test result is passed, see the attachment1- test report of retained sample.4.Root cause cannot be confirmed.5.The plant continue pay attention to this defect.H3 other text : see narrative.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18238133
• MDR Text Key: 329378933
• Report Number: 3014704491-2023-00776
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903886388
• UDI-Public: (01)00382903886388
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 388638
• Device Lot Number: 2286528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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