MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTROSYTE-N AUTOGUARD INTRODUCER; CATHETER INTRODUCER

Catalog Number UNKNOWN

Device Problem Break (1069)

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.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.(b)(4).

Event Description

It was reported that the unspecified bd introsyte-n" autoguard introducer did not split as intended during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "we received a defective lot of peripheral inserted central catheter.A piece of the item broke off of the cath into a patient." "to clarify: the device that failed was not retained in the patient.Its failure would be better described as the catheter would not peel apart as designed.The picc insertion team had a choice (and went with option 3  it eventually worked): remove the newly inserted infant picc line 2.Cut the bulk of the insertion catheter and leave it encapsulating the picc line, securing it distally (near the hub) 3.Pick at the insertion catheter and try to get it to separate and lift off the picc line without damaging the picc line." "i can confirm that it was not the picc that failed, it was the peel away introducer.Unfortunately we did not retain the correct device packaging, therefore i cannot guarantee the lot number of the device.However it is highly probable that it matches the lot # of the device shown below (0087981).There was no foreign body retained in the patient.At this time there is no noted harm to the patient as a result of the issue.".

Manufacturer Narrative

After further review mfr#: 2243072-2021-00057 is cancelled.The device referenced is a concomitant device.As a result mfr#: 2243072-2021-00057 is null and void.

Event Description

It was reported that the unspecified bd introsyte-n¿ autoguard introducer did not split as intended during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "we received a defective lot of peripheral inserted central catheter.A piece of the item broke off of the cath into a patient." "to clarify: the device that failed was not retained in the patient.Its failure would be better described as the catheter would not peel apart as designed.The picc insertion team had a choice (and went with option 3 ¿ it eventually worked): 1.Remove the newly inserted infant picc line 2.Cut the bulk of the insertion catheter and leave it encapsulating the picc line, securing it distally (near the hub) 3.Pick at the insertion catheter and try to get it to separate and lift off the picc line without damaging the picc line." " i can confirm that it was not the picc that failed, it was the peel away introducer.Unfortunately we did not retain the correct device packaging, therefore i cannot guarantee the lot number of the device.However it is highly probable that it matches the lot # of the device shown in the photo below (0087981).There was no foreign body retained in the patient.At this time there is no noted harm to the patient as a result of the issue.".

• Brand Name: UNSPECIFIED BD INTROSYTE-N AUTOGUARD INTRODUCER
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11143320
• MDR Text Key: 226027173
• Report Number: 2243072-2021-00057
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1