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

Catalog Number 383069

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284)

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

Event Date 10/29/2023

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 y 22gax1.00in prn ec slm npvc packaging was damaged the following information was provided by the initial reporter; on (b)(6) 2023 nurse (b)(6) puncture indwelling needle for the patient, after checking and found that the indwelling needle package leakage, is no longer aseptic.

Manufacturer Narrative

1.Dhr/bhr review (lot#: 2314750): 1) this batch of products were assembled at intima ii auto line 3 in november 2022, and packaged at r240 package line and cfs package line in november 2022.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.2.No actual samples and pictures have been received for the complaint.3.Check the unit packages of the retained samples of this batch, and no poor seal, broken top web or broken bottom film is found.Please see attachment for the check 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 samples.No similar complaints have been received from other hospitals regarding this batch of products.As the specific site and state of the leakage of the package cannot be confirmed, the root cause of this defect cannot be determined.

Event Description

No additional information provided.

• Brand Name: BD INTIMA-II Y 22GAX1.00IN PRN EC 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: 18238608
• MDR Text Key: 329383685
• Report Number: 3014704491-2023-00777
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830695
• UDI-Public: (01)00382903830695
• 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: 12/29/2023

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: 383069
• Device Lot Number: 2314750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1