MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II 18GAX1.16IN PRN SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383050

Device Problem Separation Problem (4043)

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

Event Date 10/16/2023

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 intima-ii 18gax1.16in prn slm npvc leaked at septum the case when the white stopper is brought out when the needle core is removed; whether the sample can be returned, you need to reply to the acceptance email after confirmation, and photos are provided; need a complaint reply letter; no green claim is required, saying that the follow-up return and exchange process.

Manufacturer Narrative

1.Dhr/bhr review(lot#1293723): 1)this batch of products were assembled at intima ii auto line 4 in (b)(6) 2021, and packaged at r240 package line in (b)(6) 2021.Work order quantity was (b)(4).2)review the in-process test reports and outgoing test reports, and all test results meet the product specifications.3)review the production records with no nonconformance, deviation or rework activities.2.The customer returned 1 unused sample, the sku is 383050, the batch code is 1293723.1)the distribution of uv adhesive in the catheter hub is checked under the purple lamp.No abnormality is found in the sample.Please see attachment (b)(4) for the photos.2)45psi leakage test is carried out on the sample, no leakage is found, and no abnormality is observed on the septum.Please see attachment (b)(4) for the test report.3.Two retained samples of this batch are taken for 45psi leakage test.The samples pass the test and the septums are abnormal.Please see attachment (b)(4) for the test report.Uv adhesive is distributed in place in the catheter hubs.Please see attachment (b)(4) for the photos.4.The septum and the catheter hub are bonded by uv adhesive.After the adhesive is dried, the visual inspection system conducts 100% inspection, which will automatically identify and remove defective products.The visual inspection system is challenged with standard samples every day at 7:00, 19:00 and when changing product gauge to ensure the effectiveness of the inspection.5.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process and retained samples, and no abnormality is found in the relevant tests of the returned replacement sample of the complaint batch.Therefore, the root cause of the septum being brought out during needle core withdrawal cannot be determined.This complaint defect first appeared, and the plant will continue to pay attention.

Event Description

No additional information provided.

• Brand Name: BD INTIMA-II 18GAX1.16IN PRN SLM NPVC
• 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: 18077741
• MDR Text Key: 327703971
• Report Number: 3014704491-2023-00713
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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: 383050
• Device Lot Number: 1293723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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