MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ PRO IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 391380

Device Problem Material Puncture/Hole (1504)

Patient Problems Erythema (1840); Pain (1994)

Event Date 03/17/2022

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 while using bd neoflon¿ pro iv catheter the needle has gone through the catheter.There was no report of patient impact.The following information was provided by the initial reporter: tip of the needle is blunt and hard to insert, cannula is to soft and to flexible.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 21-jul-2022.H6: investigation summary: five photos and two representative samples were received by our quality team for evaluation.From the first two photos, one 26g neoflon pro used sample was observed with the needle pierced through the catheter.A blunt needle cannot be seen clearly from the photo.The third and fourth photos, a patient¿s arm was observed with redness around the wrist area.The fifth photo shows a top web of batch 9242213 and a top web of batch 0081014.The top web of batch 0081014 does not belong to the reported complaint.The representative samples returned are of batch 9263838 and 9353151.Both samples do not belong to the reported complaint.The returned samples were subjected to visual inspection and penetration testing.The samples passed the acceptance criteria, and no abnormalities were observed.A review of the internal manufacturing device records and raw material history files for the reported and unreported lot numbers was performed and no recorded quality problems or rejections to this incident were found.From the returned photos, blood was observed in the catheter.This indicates a successful penetration.It would not be possible to penetrate the vein if the product has the needle pierced through the catheter.Therefore, the probable root cause for the reported defect could be due to the user having partially withdrawing the needle from the catheter and upon reinserting the needle into the vein, the needle pierced through the catheter and damaged the catheter.The manufacturing process was reviewed.There is a 100% online automated vision inspection system that can detect and reject product not meeting the lie distance requirement.If the cannula pierced through the catheter in the manufacturing process, the defect part would be rejected by the automated vision inspection system as the product will not have any lie distance.The sterilization records were reviewed, and no abnormalities were observed.Based on the quality team's investigation, the root cause of this incident cannot be determined.

Event Description

It was reported while using bd neoflon¿ pro iv catheter the needle has gone through the catheter.There was no report of patient impact.The following information was provided by the initial reporter: tip of the needle is blunt and hard to insert, cannula is to soft and to flexible.

Event Description

It was reported while using bd neoflon¿ pro iv catheter the needle has gone through the catheter.There was no report of patient impact.The following information was provided by the initial reporter: tip of the needle is blunt and hard to insert, cannula is to soft and to flexible.

Manufacturer Narrative

The following fields were corrected: d9: device available for eval no.D9: returned to manufacturer on: na.H6: investigation summary : five photos were received by our quality team for evaluation.From the first two photos, a 26g neoflon pro used sample was observed with the needle pierced through the catheter.A blunt needle cannot be seen clearly from the returned photos.From photos three and four, a patient¿s arm was observed with redness around the wrist area.The fifth photo shows a top web of batch 9242213 of catalog 391380 and one top web of batch 0081014 of catalog 391379, which does not belong to the reported complaint.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.From the returned photos, blood was observed in the catheter.This indicates a successful penetration.It would not be possible to penetrate the vein if the product has the needle pierced through the catheter.Therefore, the probable root cause for the reported defect could be due to the user partially withdrawing the needle from the catheter and upon reinsertion, the needle pierced through the catheter.The manufacturing process was reviewed.There is a 100% online automated vision inspection system that can detect and reject product not meeting the lie distance requirement.If the cannula pierced through the catheter in the manufacturing process, the defective part would be rejected by the automated vision inspection system as the product would not have any lie distance.The endotoxin level for the reported batch 9242213 and batch 0081014 are acceptable.An allergic reaction (redness / hematomas) at the site of insertion may have occurred due to an incorrect aseptic technique or damaged product package that led to a sterility breach.As no sample was returned, further investigation cannot be performed, and a root cause cannot be determined.H3 other text : see h10.

• Brand Name: BD NEOFLON¿ PRO IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14048397
• MDR Text Key: 288901839
• Report Number: 8041187-2022-00180
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2022

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: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 391380
• Device Lot Number: 9242213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 08/15/2022; 09/02/2022
• Supplement Dates FDA Received: 08/24/2022; 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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