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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

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.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 2 unspecified introsyte introducer broke at the cannula during use.The following was reported by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced needle breakage.".

Event Description

It was reported that 2 unspecified introsyte introducer broke at the cannula during use.The following was reported by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced needle breakage.".

Manufacturer Narrative

H6: 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.

Manufacturer Narrative

The following field was updated due to correction: no.Of events summarized: 2.

Event Description

It was reported that 2 unspecified introsyte introducer broke at the cannula during use.The following was reported by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced needle breakage.".

• Brand Name: UNSPECIFIED 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: 11143636
• MDR Text Key: 226015172
• Report Number: 2243072-2021-00062
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• 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: Health Professional
• 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