MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU INTIMA-II 20GAX1.16IN PRN SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383057

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/20/2023

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 intima-ii 20gax1.16in prn slm npvc had foreign matter in the device.The following information was provided by the initial reporter, translated from chinese to english: when the clinical nurse teacher opened the company's 20g, she found that there was a black block in the transparent needle of the indwelling needle, and immediately fed it back to me, and then replaced it with another indwelling needle the hospital wanted to know why this was the case.

Manufacturer Narrative

1.The customer returned 4 photos and 1 defective sample, the sku is 383057, the batch code is 2263938, there is a black foreign matter in the catheter hub, which looks like a coating.Please see attachment pr#9440829-1 for the photos.1)the sample is sent to bd r&d laboratory for ftir testing on the foreign matter.Two methods of detection fail to detect what the foreign matter is.Please see attachment pr#9440829-2 for the test report.2)it is suspected that the black foreign matter is the burnt spot produced by the carbonization of the catheter hub during molding (the carbonized material has no infrared signal because there is no structural group).There are flowing blind spots in the molding machine's screw and hot runner system of die, and the molten catheter hub material is carbonized into burnt spots in these places at high temperature for a long time.Action taken: the molding machine's screw and hot runner system of die are cleaned with pp every quarter to reduce the occurrence of the burnt spot.2.Dhr/bhr review(lot#2263938): 1)this batch of products were assembled at intima ii auto line 4 in (b)(6) 2022, and packaged at cfs package line in (b)(6) 2022.Work order quantity was 99,000 ea.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.3.Check the retained samples of this batch, and no similar foreign matters are found.Please see attachment pr#9440829-3 for the inspection report.4.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found in process and retained samples.There is a black foreign matter in the catheter hub of the returned sample, which is suspected to be the burnt spot generated during the molding of the catheter hub.Its origin is uncertain because the relevant tests do not determine its composition.This complained defect is first encountered, the plant will continue to track and pay attention to.

Event Description

No additional information provided.

• Brand Name: INTIMA-II 20GAX1.16IN PRN SLM NPVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• 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: 18476358
• MDR Text Key: 333015299
• Report Number: 3014704491-2023-00898
• 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: 02/12/2024

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: 383057
• Device Lot Number: 2263938
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1