MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II 24GAX0.75IN PRN SLM; CATHETER

Catalog Number 383028

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/08/2020

Event Type  Injury  

Manufacturer Narrative

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 intima-ii 24gax0.75in prn slm separated after placement.The following information was provided by the initial reporter: "(b)(6)year-old boy was injected with the needle on the back of right hand, after the treatment and going back home with the needle, the catheter was broken in the blood vessel of the body, the section of the tube was in half to two-thirds of the length of the fracture, so the boy was back to the hospital for treatment, at the night of 8 march , the child had scanned with ct , it was suspected in the small intestine, there is no discharge (according to the head nurse of hospital that was likely to be a child's bit, eventually reason was not sure) and unknown reason caused this fracture.At present, the patient's condition and mood were stable, and the hospital is relatively stable; photos could be provided when samples are returned without defects; no need of green claims; requested to issue a formal report and deal with it as soon as possible.".

Event Description

It was reported that intima-ii 24gax0.75in prn slm separated after placement.The following information was provided by the initial reporter: "3 year-old boy was injected with the needle on the back of right hand, after the treatment and going back home with the needle, the catheter was broken in the blood vessel of the body, the section of the tube was in half to two-thirds of the length of the fracture, so the boy was back to the hospital for treatment, at the night of 8 march , the child had scanned with ct , it was suspected in the small intestine, there is no discharge (according to the head nurse of hospital that was likely to be a child's bit, eventually reason was not sure) and unknown reason caused this fracture.2.At present, the patient's condition and mood were stable, and the hospital is relatively stable; 3.Photos could be provided when samples are returned without defects; 4.No need of green claims; 5.Requested to issue a formal report and deal with it as soon as possible".

Manufacturer Narrative

H.6.Investigation summary a device history review was conducted for lot number 9197414.Our records show that this is the only instance of this issueoccurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue and encourages you to submit your sample for review.

• Brand Name: INTIMA-II 24GAX0.75IN PRN SLM
• Type of Device: CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9898412
• MDR Text Key: 187102222
• Report Number: 3006948883-2020-00102
• 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: 04/06/2020

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: Other
• Device Expiration Date: 08/14/2022
• Device Catalogue Number: 383028
• Device Lot Number: 9197414
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 03/08/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other