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

Catalog Number UNKNOWN

Device Problem Packaging Problem (3007)

Patient Problems Bruise/Contusion (1754); Pain (1994)

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 (b)(4) has been listed and the (b)(4) 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.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 the unspecified bd introsyte" introducers packaging seal was not intact.The following information was provided by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced hematoma, introducer difficult to remove from vein, package seal not intact before use (breach in package integrity), and pain.".

Manufacturer Narrative

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

Event Description

It was reported that the unspecified bd introsyte¿ introducers packaging seal was not intact.The following information was provided by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced hematoma, introducer difficult to remove from vein, package seal not intact before use (breach in package integrity), and pain.".

• Brand Name: UNSPECIFIED BD INTROSYTE INTRODUCER
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11170432
• MDR Text Key: 226829419
• Report Number: 2243072-2021-00111
• 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
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• 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: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1