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

Catalog Number UNKNOWN

Device Problems Break (1069); Leak/Splash (1354); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Device expiration date: unknown.Initial reporter phone #: an additional phone # was provided as: (b)(6).Device manufacture date: unknown.(b)(4).

Event Description

It was reported that unspecified bd introsyte¿ introducer experienced 2 cases of device damage/deformation while still considered operable, 1 case of a needle that broke/detached, 1 case of a broken sheath, and 2 cases of sheath breakage/separation.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Introducer breakage / defective or damaged introducer needle broke.Splittable introducer sheath separated and broke off in the patients vein introducer was difficult to thread.Splittable sheath did not completely separate / introducer did not peel apart correctly introducer was used to insert a picc or other device but the device would not advance incorrect needle bevel orientation introducer needle dull / blunt.

Manufacturer Narrative

H6: investigation summary: bd  was unable to  perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.H3 other text : see h.10.

Event Description

It was reported that unspecified bd introsyte· introducer experienced 2 cases of device damage/deformation while still considered operable, 1 case of a needle that broke/detached, 1 case of a broken sheath, and 2 cases of sheath breakage/separation.The following information was provided by the initial reporter: material no: unknown batch no: unknown introducer breakage / defective or damaged introducer needle broke.Splittable introducer sheath separated and broke off in the patient¿s vein introducer was difficult to thread splittable sheath did not completely separate / introducer did not peel apart correctly introducer was used to insert a picc or other device but the device would not advance incorrect needle bevel orientation introducer needle dull / blunt.

Event Description

It was reported that unspecified bd introsyte· introducer experienced 2 cases of device damage/deformation while still considered operable, 1 case of a needle that broke/detached, 1 case of a broken sheath, and 2 cases of sheath breakage/separation.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Introducer breakage / defective or damaged introducer.Needle broke.Splittable introducer sheath separated and broke off in the patient¿s vein introducer was difficult to thread.Splittable sheath did not completely separate / introducer did not peel apart correctly introducer was used to insert a picc or other device but the device would not advance incorrect needle bevel orientation.Introducer needle dull / blunt.

Manufacturer Narrative

The following field was updated due to correction: h6.

• 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: 11143743
• MDR Text Key: 226013282
• Report Number: 2243072-2021-00066
• 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: 01/09/2021
• 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