MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN; UNKOWN

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

Patient Problem Foreign Body Embolism (4439)

Event Date 09/13/2023

Event Type  Injury  

Event Description

It was reported unspecified bd product catheter broke.The following information was provided by the initial reporter; verbatim: a piece of an iv catheter was retained in the patient after discontinuation.Ultrasound shows a small echogenic structure within the subcutaneous soft tissues measuring up to 1 cm length concerning for foreign body that could potentially be a piece of fragmented iv catheter.Follow-up with a vascular surgeon is pending at this time; the treatment plan is unknown at this time and the fragment is currently located in the patient's upper extremity.If extracted, it will be returned to the manufacturer.

Manufacturer Narrative

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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.See narrative below.

Event Description

No additional information available.

• Brand Name: UNKNOWN
• Type of Device: UNKOWN
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18029050
• MDR Text Key: 326845075
• Report Number: 2243072-2023-01915
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/07/2023
• 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