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 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).The customer's address is unknown: ¿(b)(6) usa has been used as a default.¿ 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 an unspecified bd introsyte" introducer experienced device damage/deformation while still considered operable and a damaged/defective sheath.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Introducer was difficult to thread.Introducer was used to insert a picc or other device but the device would not advance.Introducer difficult to remove from vein.

Event Description

It was reported that an unspecified bd introsyte¿ introducer experienced device damage/deformation while still considered operable and a damaged/defective sheath.The following information was provided by the initial reporter: material no: unknown batch no: unknown introducer was difficult to thread.Introducer was used to insert a picc or other device but the device would not advance.Introducer difficult to remove from vein.

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 could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

• 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: 11143742
• MDR Text Key: 226015520
• Report Number: 2243072-2021-00067
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/09/2021
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1