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

Catalog Number UNKNOWN

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Information (3190)

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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes 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.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.Fda device problem code: (b)(4).Fda patient problem code: (b)(4).

Event Description

It was reported that the unspecified bd introsyte¿ introducers splittable sheath separated and broke off in the patient's vein, and did not split as intended.The following information was provided by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced splittable introducer sheath separated and broke off in the patient¿s vein, splittable sheath did not completely separate / introducer did not peel apart correctly and plastic tip of introducer seemed to stick / adhere to the catheter.".

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 h10.

Event Description

It was reported that the unspecified bd introsyte¿ introducers splittable sheath separated and broke off in the patient's vein, and did not split as intended.The following information was provided by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced splittable introducer sheath separated and broke off in the patient¿s vein, splittable sheath did not completely separate / introducer did not peel apart correctly and plastic tip of introducer seemed to stick / adhere to the catheter.".

• Brand Name: UNSPECIFIED BD INTROSYTE INTRODUCER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11131395
• MDR Text Key: 225566781
• Report Number: 2243072-2020-02305
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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: Health Professional
• 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: 01/07/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1