MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTROSYTE INTRODUCER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Hematoma (1884)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.Unknown, new jersey, 00000 usa has been used as a default.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.Fda device problem code: (b)(4).Fda patient problem code: (b)(4).

Event Description

It was reported that 2 unspecified bd introsyte¿ introducer splittable sheaths were defective and would not spit as intended, and 1 introducers needle broke/pulled out of the hub.The following information was provided by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced".

Event Description

It was reported that 2 unspecified bd introsyte¿ introducer splittable sheaths were defective and would not spit as intended, and 1 introducers needle broke/pulled out of the hub.The following information was provided by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced.".

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no material number, sample, lot, or batch number were provided.Dhr could not be performed because of the unknown lot#.The complaint could not be confirmed and the root cause is undetermined.

• Brand Name: UNSPECIFIED BD INTROSYTE INTRODUCER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11131693
• MDR Text Key: 225559571
• Report Number: 2243072-2020-02308
• 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: other
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1