MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON YEL 24GA IV CANNULA; INTERVASCULAR CATHETER

Catalog Number 391350

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Tissue Damage (2104)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8109407, medical device expiration date: 2023-04-30, device manufacture date: 2018-04-19.Medical device lot #: 8052236, medical device expiration date: 2023-02-28, device manufacture date: 2018-03-15.Medical device lot #: 7354447, medical device expiration date: 2022-12-31, device manufacture date: 2018-02-08.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 that an unspecified number of neoflon yel 24ga iv cannulas caused medical intervention in the form of a bolus dosage due to a delay in treatment caused by an inability to apply the catheter.The incident took place during use of the device.The following information was provided by the initial reporter: the last year customer reported a complaint regarding neoflon - purple and yellow.Recently they were experiencing the same problem.Catheter peels back and therefore neonate had to be punctured several times.Later start with fluid/medication.Sometimes a higher dosage to make up for lost time.

Event Description

It was reported that an unspecified number of neoflon yel 24ga iv cannulas caused medical intervention in the form of a bolus dosage due to a delay in treatment caused by an inability to apply the catheter.The incident took place during use of the device.The following information was provided by the initial reporter: the last year customer reported a complaint regarding neoflon - purple and yellow.Recently they were experiencing the same problem.Catheter peels back and therefore neonate had to be punctured several times.Later start with fluid/medication.Sometimes a higher dosage to make up for lost time.

Manufacturer Narrative

The following field has been updated due to corrected information: h.1.Type of reportable event: serious injury.H.6.Investigation: 3 used samples (batch #7323158-1pcs, #8109407-1pcs and #8094499-1pcs) were returned for investigation.The used samples were subjected to visual inspection.Peelback was observed on the used samples.The complaint is confirmed and product is out of specification.The probable root cause for peelback could be due to tubing material.Capa#81917 was issued to review the tubing material.Dhr was performed and no qn or abnormality was observed that could have influenced the issue.H3 other text : see h.10.

• Brand Name: NEOFLON YEL 24GA IV CANNULA
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8729075
• MDR Text Key: 149702780
• Report Number: 8041187-2019-00485
• 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: 07/18/2019

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 Catalogue Number: 391350
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other