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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Initial reporter phone #: an additional phone # was provided as (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.(b)(4).

Event Description

It was reported that an unspecified bd introsyte introduce experienced a sheath that would not split as intended.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via introsyte introducer survey that the clinician experienced hematoma, splittable sheath did not completely separate / introducer did not peel apart correctly and introducer was used to insert a picc or other device but the device would not advance.

Event Description

It was reported that an unspecified bd introsyte introduce experienced a sheath that would not split as intended.The following information was provided by the initial reporter: material no: unknown.Batch no: unknown.It was reported via introsyte introducer survey that the clinician experienced hematoma, splittable sheath did not completely separate / introducer did not peel apart correctly and introducer was used to insert a picc or other device but the device would not advance.

Manufacturer Narrative

Investigation summary: bd was unable to perform a thorough investigation as no material number, sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.

• Brand Name: UNSPECIFIED BD INTROSYTE INTRODUCER
• Type of Device: PICC INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11135451
• MDR Text Key: 227066619
• Report Number: 2243072-2021-00025
• Device Sequence Number: 1
• Product Code: DYB
• 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: 01/14/2021

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: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1