MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II 24GAX0.56IN PRN SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383085

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Code Available (3191)

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported a safety mechanism issue was found during use with a intima-ii 24gax0.56in prn slm npvc.The following information was provided by the initial reporter, on (b)(6) 2019, the child was admitted to hospital due to bronchial pneumonia.On the first day of admission, the nurse found that the needle core could not be removed when giving infusion to the child, and then other indwelling needles were replaced for puncture, resulting in the second puncture of the child without any other influence.

Manufacturer Narrative

H.6.Investigation: no photo or sample was provided to aid in our quality engineer¿s investigation.With the lack of a sample, bd was unable to observe the failure mode and a root cause could not be determined.Master production records were reviewed for the lot number and no non-conformances were noted during the manufacturing of this lot.Our records indicate that the reviewed batch record passed all the in-process inspection.

Event Description

It was reported a safety mechanism issue was found during use with a intima-ii 24gax0.56in prn slm npvc.The following information was provided by the initial reporter, on (b)(6) 2019, the child was admitted to hospital due to bronchial pneumonia.On the first day of admission, the nurse found that the needle core could not be removed when giving infusion to the child, and then other indwelling needles were replaced for puncture, resulting in the second puncture of the child without any other influence.

• Brand Name: INTIMA-II 24GAX0.56IN PRN SLM NPVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9396971
• MDR Text Key: 180208698
• Report Number: 3006948883-2019-00992
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Catalogue Number: 383085
• Device Lot Number: 7234120
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other