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.

• 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
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8982448
• MDR Text Key: 158788291
• Report Number: 2243072-2019-01962
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/10/2019 Patient Sequence Number: 1