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

Catalog Number UNKNOWN

Device Problem Break (1069)

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.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 3 unspecified bd introsyte¿ introducer experienced sheaths that would not split as intended.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Hematoma.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.

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.

Event Description

It was reported that 3 unspecified bd introsyte¿ introducer experienced sheaths that would not split as intended.The following information was provided by the initial reporter: material no: unknown; batch no: unknown.Hematoma.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.

Manufacturer Narrative

The following field was updated due to correction: h: no.Of events summarized: 3.

Event Description

It was reported that 3 unspecified bd introsyte¿ introducer experienced sheaths that would not split as intended.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Hematoma.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.

• 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: 11143603
• MDR Text Key: 226016300
• Report Number: 2243072-2021-00068
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 3
• 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

• 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
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/09/2021
• Supplement Dates Manufacturer Received: 01/29/2021; 07/08/2022
• Supplement Dates FDA Received: 01/31/2021; 07/29/2022
• 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