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

Catalog Number UNKNOWN

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.Medical device expiration date: unknown.Initial reporter additional phone#: (b)(6).The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that unspecified bd" introsyte introducer was damaged.This occurred on 6 occasions.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 needle breakage.

Manufacturer Narrative

H.6.Investigation: bd  was unable to  perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint is unconfirmed and the root cause can't be determined.

Event Description

It was reported that unspecified bd¿ introsyte introducer was damaged.This occurred on 6 occasions.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 needle breakage.

Event Description

It was reported that unspecified bd¿ introsyte introducer was damaged.This occurred on 6 occasions.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 needle breakage.

Manufacturer Narrative

The following field was updated due to correction: no.Of events summarized: 6.

• 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: 11143509
• MDR Text Key: 226018158
• Report Number: 2243072-2021-00056
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,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: 01/08/2021
• 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