MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD IV SAFETY CATHETER; IV CATHETER

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Initial reporter phone# (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified number of the unspecified bd iv safety catheter experienced breakage during use.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Per customer email: seems we are having a new issue now that we are really cranking on the extension sets.The catheters are breaking! today we had 2 separate incidents with the new bd safety iv catheters: "chfcat" that had a prn on over the iv cath.All he did was shake his iv limb and the prn flew off with blood splattered on the o2 cage door.We caught it as it happened, so did not have the opportunity to find out if the spring in the hub would prevent bleeding out.Factious cat that can only be handled with sedation before entering cage.Lost its mind tonight and was popcorn-ing in the cage.We lost iv access as his iv catheter broke during the mayhem, wasn¿t dislodged or pulled out, still nicely taped in.Ultimately spray to facilitate sedation.

Manufacturer Narrative

H.6.Investigation summary: due to the limited amount of information provided bd was unable to perform a thorough investigation.No additional information was available after several attempts to determine the material/lot # and the physical sample was not available for investigation.Based off the provided photo bd could not determine the root cause.

Event Description

It was reported that an unspecified number of the unspecified bd iv safety catheter experienced breakage during use.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Per customer email: seems we are having a new issue now that we are really cranking on the extension sets.The catheters are breaking! today we had 2 separate incidents with the new bd safety iv catheters: chfcat that had a prn on over the iv cath.All he did was shake his iv limb and the prn flew off with blood splattered on the o2 cage door.We caught it as it happened, so did not have the opportunity to find out if the spring in the hub would prevent bleeding out.Factious cat that can only be handled with sedation before entering cage.Lost its mind tonight and was popcorn-ing in the cage.We lost iv access as his iv catheter broke during the mayhem, wasn¿t dislodged or pulled out, still nicely taped in.Ultimately spray to facilitate sedation.

• Brand Name: UNSPECIFIED BD IV SAFETY CATHETER
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8600802
• MDR Text Key: 145114698
• Report Number: 2243072-2019-00902
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other