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

Catalog Number UNKNOWN

Device Problems Break (1069); Leak/Splash (1354); Packaging Problem (3007)

Patient Problem Bruise/Contusion (1754)

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.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 10 unspecified bd introsyte¿ introducers experienced damaged or open unit packages/seal where sterility was compromised, and device damage/deformation while still considered operable.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 the introducer break/defective or damaged, hematoma and the package seal not intact before use.

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 due to unknown lot#.H3 other text : see h.10.

Event Description

It was reported that 10 unspecified bd introsyte¿ introducers experienced damaged or open unit packages/seal where sterility was compromised, and device damage/deformation while still considered operable.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 the introducer break/defective or damaged, hematoma and the package seal not intact before use.

Event Description

It was reported that 10 unspecified bd introsyte¿ introducers experienced damaged or open unit packages/seal where sterility was compromised, and device damage/deformation while still considered operable.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 the introducer break/defective or damaged, hematoma and the package seal not intact before use.

Manufacturer Narrative

H: no.Of events summarized: 10.

• Brand Name: UNSPECIFIED BD INTROSYTE¿ INTRODUCER
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11143759
• MDR Text Key: 226014933
• Report Number: 2243072-2021-00065
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 10
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1