MAUDE Adverse Event Report: BECTON DICKINSON 22G X 1.00IN (0.9 X 25 MM) INSYTE; INTERVASCULAR CATHETER

Catalog Number 381223

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 08/24/2019

Event Type  malfunction  

Manufacturer Narrative

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.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.(b)(4).

Event Description

It was reported that the 22g x 1.00in (0.9 x 25 mm) insyte experienced product damage/deformation which was noted during use.The following information was provided by the initial reporter: material no.: 381223 batch no.: unknown it was reported that the tip of the catheter broke off while it was inside the patient so it had to be removed surgically.Per phone call on 8/27/29: health professional from user facility indicated that the catheter tip broke off inside the patient.Patient was a dog.Happened early morning (b)(6) 2019.Broken piece had to be removed surgically but was retrieved and patient is stable.Possible lots 8265303 & 8265298.

Manufacturer Narrative

Additional information: multiple lot numbers: there were multiple lot numbers reported that the device could have originated from.The information for each lot number is as follows: d.4.Medical device lot #: 8265303; d.4.Medical device expiration date: 9/30/2023; h.4.Device manufacture date: 9/22/2018; d.4.Medical device lot #: 8265298; d.4.Medical device expiration date: 9/30/2023; h.4.Device manufacture date: 9/22/2018.H.6.Investigation summary: one sample was returned for evaluation.From the sample, a sharp and flat cut was observed on the catheter.The investigation was not able to confirm what the customer had experienced as sample does not show that catheter broken after placement.Based on the broken edge, no stretched phenomenon or elongation of the catheter tubing can be observed to indicate any issue with the tubing material which could have caused the breakage.Based on the investigation and analysis, the root cause of the reported conformance cannot be determined.The non-conformance could happen out of the manufacturing facility or during product application.Part of the outgoing inspection, there is catheter pull test which the part was released upon passed the outgoing inspection.H3 other text : see section h.10.

Event Description

It was reported that the 22g x 1.00in (0.9 x 25 mm) insyte experienced product damage/deformation which was noted during use.The following information was provided by the initial reporter: material no.: 381223; batch no.: unknown.It was reported that the tip of the catheter broke off while it was inside the patient so it had to be removed surgically.Per phone call on (b)(6) 29: health professional from user facility indicated that the catheter tip broke off inside the patient.Patient was a dog.Happened early morning (b)(6) 19.Broken piece had to be removed surgically but was retrieved and patient is stable.Possible lots 8265303 & 8265298.

• Brand Name: 22G X 1.00IN (0.9 X 25 MM) INSYTE
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8982448
• MDR Text Key: 158788291
• Report Number: 2243072-2019-01962
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812234
• UDI-Public: 30382903812234
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381223
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other