MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II 22GAX1.00IN PRN SLM; INTRAVASCULAR CATHETER

Catalog Number 383014

Device Problem Defective Device (2588)

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

Event Date 10/31/2023

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 22gax1.00in prn slm tubing was defective/damaged the following information was provided by the initial reporter; on (b)(6) 2023, in the department of integrated traditional chinese and western medicine oncology, the patient needed radiotherapy positioning for cervical cancer.The radiotherapy positioning required the placement of a closed intravenous indwelling needle.The nurse placed the indwelling needle in the patient.After it was properly fixed, the patient underwent enhanced ct during radiotherapy positioning and injecting iodine contrast agent, the extension tube of the indwelling needle ruptures and the patient's blood flows out.The indwelling needle is removed immediately and a new closed intravenous indwelling needle is replaced, which can be used normally.

Event Description

No additional information provided.

Manufacturer Narrative

1.The customer returned 3 photos, no actual sample.The photos show: the sku is 383014, the batch code is 3108422, the middle of the extension tubing is ruptured.2.Dhr/bhr review(lot#3108422): 1) this batch of products were assembled at intima ii auto line 3 in june 2023, and packaged at r240 package line in june 2023.Work order quantity was (b)(4) 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.Functional test (45psi leakage test) is conducted on the retained sample of the complained batch.The leakage test is passed, and no abnormality is found at the extension tubing.Please refer to the attached test report.4.Sku#383014 is an intima ii product (pvc extension tubing).The intended use for the bd intima ii product is the intravascular administration of fluids.The forcing of liquid through the product during enhanced ct may cause the extension tubing to rupture.5.This product has never been declared to be used for high-pressure injection.6.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process and retained sample.No similar complaints have been received from other hospitals regarding this batch of products.The returned photo shows a rupture in the middle of the extension tubing, and since the product is not suitable for high pressure injection, the root cause of the defect is related to the incorrect use of the product.

• Brand Name: BD INTIMA-II 22GAX1.00IN PRN SLM
• 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: 18247473
• MDR Text Key: 329494473
• Report Number: 3014704491-2023-00783
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830145
• UDI-Public: (01)00382903830145
• 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: 12/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383014
• Device Lot Number: 3108422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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