MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/17/2022

Event Type  Injury  

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.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.

Event Description

It was reported that the unspecified bd intravascular catheter experienced a broken needle.The patient received medical testing and surgical intervention, but the broken cannula piece was not found.The following information was provided by the initial reporter: a peripheral iv appeared to have broken off in a patient's vein.Could not be confirmed on us or xr.Had to have an incision with vascular surgery and it was not found/retrieved.What was the patient¿s outcome? upper extremity us, vascular surgery consult/ 2cm incision to look for sheath in vein.No retained sheath found.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photographs provided for evaluation.Bd received two photographs which displayed sufficient evidence to confirm the reported defect of the catheter breaking after placement.Damage to the catheter tubing that leads to it being separated from the catheter adaptor can happen both in manufacturing environment and during application.The second photo provided shows the defective catheter adapter that appears to be missing a catheter tubing and the photo has a very limited view of the defective site.In order to perform a comprehensive investigation for this defect a physical sample of the adaptor and catheter tubing is preferred so the separation site can be inspected microscopically.No further investigation can be performed to determine the root cause in the absence of physical sample and/ or more detailed pictures of the failed device.

Event Description

It was reported that the unspecified bd intravascular catheter experienced a broken needle.The patient received medical testing and surgical intervention, but the broken cannula piece was not found.The following information was provided by the initial reporter: a peripheral iv appeared to have broken off in a patient's vein.Could not be confirmed on us or xr.Had to have an incision with vascular surgery and it was not found/retrieved.What was the patient¿s outcome? upper extremity us, vascular surgery consult/ 2cm incision to look for sheath in vein.No retained sheath found.

• Brand Name: UNSPECIFIED BD INTRAVASCULAR 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: 14465520
• MDR Text Key: 292349478
• Report Number: 2243072-2022-00719
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• 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: 07/08/2022
• 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