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

Catalog Number 383078

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd intima-ii 24gax0.75in prn slm npvc was difficult to clamp the following information was provided by the initial reporter; (b)(6).2023 bd closed iv indwelling needle did not feed easily during puncture, and the snaps were too loose during sealing resulting in hose slippage causing sealing failure.

Manufacturer Narrative

The event details have been reviewed and it is reported that a loose clamp has occurred.The applicable fmea/eura indicates that the potential risk of the reported event was assessed appropriately.  a retrospective review of complaints for this event reveals no reports of serious injury.This complaint is not mdr reportable.

Event Description

On (b)(6) 2023 bd closed iv indwelling needle did not feed easily during puncture, and the snaps were too loose during sealing resulting in hose slippage causing sealing failure.

Manufacturer Narrative

1.Dhr/bhr review(lot#3108473): 1)this batch of products were assembled at intima ii auto line 2 in may 2023, and packaged at r240 package line in may 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.2.No actual samples and photos have been received for the complaint.3.The retained sample of this batch is taken for lie distance test, penetration force test and clamping force test of the pinch clamp, and the test results are all within the product specifications.Please see attachment pr# (b)(4) for the test reports.4.The difficulty of needle feed during puncture may be related to product quality, patient's skin and vascular conditions, and puncture method.According to the experience of previous market visits, it is recommended to insert the needle at 15°~30° with the bevel of the needle tip upwards, then lower the angle to 5°~10° to send the needle and catheter into the vessel, never reinsert the needle into the catheter.5.It was found in previous tests that when the extension tubing was not centered in the pinch clamp, the pinch clamp could not be fully acted.(please see attachment pr# (b)(4) for the clamping position view.) 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.Since the defect status of the complained sample is not identifiable, and the usage is unknown, the root cause of the complaint defects cannot be determined.The plant will continue to track and trend for the issue.

Event Description

No additional information provided.

• Brand Name: BD INTIMA-II 24GAX0.75IN 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: 18320754
• MDR Text Key: 330467287
• Report Number: 3014704491-2023-00811
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830787
• UDI-Public: (01)00382903830787
• 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,Followup
• Report Date: 01/03/2024

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: 383078
• Device Lot Number: 3108473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 10/23/2023; 01/03/2024
• Supplement Dates FDA Received: 12/19/2023; 01/17/2024
• 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