MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ANGIOCATH IV CATHETER FOR SPECIAL PLACEMENT 14 GA X 5.25 IN; INTRAVASCULAR CATHETER

Model Number	382269
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the bd angiocath¿ iv catheter for special placement 14 ga x 5.25 in experienced a catheter that broke/separated from the hub.The following information was provided by the initial reporter: this time we are fairly certain the catheter has broken and remained in the horse.This time it looks like it has cleanly separated.The horse was administered fluids and medications via the catheter and there does not seem to be any indication that they went subcutaneous.We have kept the catheter and fortunately have been able to locate the packet it was in.We have pulled these from circulation in the equine hospital for now until we have a better understanding of what may have happened.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 11/10/2020.H.6.Investigation: a device history record review was performed for provided lot number 9175198 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, two physical samples were returned for evaluation by our quality engineer team.One of the samples was a representative sample in good condition, while the second sample was received with only the adapter end and no catheter.The representative sample was evaluated and functionally tested and all of the results were per specification.The faulty sample was examined and no defects or damages that could have resulted in catheter separation or breakage were observed.At this time, an exact cause related to the manufacturing process cannot be confirmed for this incident.
Event or Problem Description
It was reported that the bd angiocath¿ iv catheter for special placement 14 ga x 5.25 in experienced a catheter that broke/separated from the hub.The following information was provided by the initial reporter: this time we are fairly certain the catheter has broken and remained in the horse.This time it looks like it has cleanly separated.The horse was administered fluids and medications via the catheter and there does not seem to be any indication that they went subcutaneous.We have kept the catheter and fortunately have been able to locate the packet it was in.We have pulled these from circulation in the (b)(6) hospital for now until we have a better understanding of what may have happened.

• Brand Name: BD ANGIOCATH IV CATHETER FOR SPECIAL PLACEMENT 14 GA X 5.25 IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10857076
• Report Number: 9610847-2020-00360
• Device Sequence Number: 19630750
• Product Code: FOZ
• UDI-Device Identifier: 30382903822691
• UDI-Public: 30382903822691
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: 382269
• Device Catalogue Number: 382269
• Device Lot Number: 9175198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1