MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 24GAX0.75IN PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383033

Device Problem Break (1069)

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

Event Date 12/22/2023

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.E1: address information was not provided, therefore, xx was used as a place holder.

Event Description

It was reported that bd intima-ii y 24gax0.75in prn/ec slm had a broken clamp.The following information was provided by the initial reporter, translated from chinese to english: the patient was given fluids using this closed iv indwelling needle as prescribed, and the small clip of the indwelling needle was found to be broken.

Manufacturer Narrative

1.Dhr/bhr review(lot#3199612): 1)this batch of products were assembled at intima ii auto line 2 in august 2023, and packaged at r240 package line in august 2023.Work order quantity was 198,000 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.4)the pinch clamp batch used in this batch of products is 3202081, review the raw material inspection records, no abnormalities.2.No actual samples and pictures have been received, and the breakage state of the pinch clamp cannot be identified.3.The retained sample of the complaint batch is taken for the pinch clamp sealing pressure test (test process: the extension tubing is clamped in the same position by the pinch clamp for more than 64 times, and then kept in the clamped state under 800mm pressure device for 3 days), test results: no abnormality is found at the pinch clamp, and no leakage is occured at the extension tubing.Please see attachment for the test report.4.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, and no similar complaints have been received from other hospitals regarding this batch of products.As the defect status of the complained sample cannot be identified, the root cause of the breakage of the pinch clamp cannot be determined, and the plant will continue to focus on such defects.H3 other text : see narrative.

Event Description

No additional information provided.

• Brand Name: INTIMA-II Y 24GAX0.75IN PRN/EC 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: 18574705
• MDR Text Key: 334731782
• Report Number: 3014704491-2024-00035
• 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: 03/15/2024

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: 383033
• Device Lot Number: 3199612
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1