MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ 20G IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/27/2022

Event Type  Injury  

Event Description

It was reported that the unspecified bd¿ 20g iv catheter broke from the hub after placing it.The patient required imaging to reveal the broken part of the catheter in the lower left pulmonary artery, and was sent to radiology to remove it.However, further imaging could not identify the fragment, and no procedure was performed.The following information was provided by the initial reporter: ''peripheral 20 gauge in left antecubital area iv was a hep lock and was found to be occluded, attempt to flush w/o suggest and iv removed.Upon removal, it was noted that only the hub was present and that the catheter was not attached.Imaging revealed subtle, linear density favored to be within the left lower lobe pulmonary artery suspicious for small bore catheter fragment.Pt was taken to interventional radiology for removal: however, further imaging was not able to identify the fragment and no procedure was performed.".

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.The customer's address is unknown.(b)(6), usa has been used as a default.Fda notified? the initial reporter also notified the fda via medwatch # mw5107866.Device manufacture date: unknown.Investigation summary: as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: UNSPECIFIED BD¿ 20G IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14136791
• MDR Text Key: 289453237
• Report Number: 2243072-2022-00489
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 03/25/2022
• 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
• Patient Outcome(s): Required Intervention