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

Catalog Number	382269
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd angiocath special orn 14ga x 5.25in catheter had broken off inside the horse.The following information was provided by the initial reporter: a bd angiocath venous catheter had been in the jugular vein of a horse since thursday afternoon (b)(6) 2021).The vein access was laid by an experienced veterinarian without complications.In the night from saturday, (b)(6) to sunday, (b)(6) the horse got a lot with a swollen catheter puncture site.The fastening skin suture was loosened to remove the venous catheter from the vein.Much to the fact that this was only about 1.5cm long.The rest of the catheter had obviously broken off.During the ultrasound examination, the rest of the catheter could no longer be found, there is a suspicion that it was carried into the right ventricle of the heart.Is the product is available for examination: yes, it can be picked up at the address of the reporting person (horse clinic at (b)(6).Were there any injuries to the user, patient or third party ?: yes, the horse is now unusable for riding due to the risk of thrombosis/pulmonary embolism, resulting in an almost complete loss of value.Additional important information: death: no, but possible in the future.Serious injury: yes.
Event or Problem Description
It was reported that bd angiocath special orn 14ga x 5.25in catheter had broken off inside the horse.The following information was provided by the initial reporter: a bd angiocath venous catheter had been in the jugular vein of a horse since thursday afternoon ((b)(6) 2021).The vein access was laid by an experienced veterinarian without complications.In the night from saturday, (b)(6) , (b)(6) the horse got a lot with a swollen catheter puncture site.The fastening skin suture was loosened to remove the venous catheter from the vein.Much to the fact that this was only about 1.5cm long.The rest of the catheter had obviously broken off.During the ultrasound examination, the rest of the catheter could no longer be found, there is a suspicion that it was carried into the right ventricle of the heart.Is the product is available for examination: yes, it can be picked up at the address of the reporting person (horse clinic at kottenforst).Were there any injuries to the user, patient or third party ?: yes, the horse is now unusable for riding due to the risk of thrombosis/pulmonary embolism, resulting in an almost complete loss of value.Additional important information: death: no, but possible in the future.Serious injury: yes.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evaluation? yes.D10: returned to manufacturer on: 2021-12-16 h6: investigation summary our quality engineer inspected the 1 sample submitted for evaluation.The reported issue was not confirmed upon inspection of the sample.The returned sample was analyzed by a quality engineer and based off our documented tolerance ranges for this product, the sample was found within specification and complete.Bd cannot confirm the cause of the failure since the reported defect was not confirmed.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD ANGIOCATH SPECIAL ORN 14GA X 5.25IN
• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12737197
• Report Number: 9610847-2021-00526
• Device Sequence Number: 19196147
• Product Code: FOZ
• UDI-Device Identifier: 00382903822690
• UDI-Public: 00382903822690
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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
• Operator of Device: Other
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 382269
• Device Lot Number: 0329670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 01/09/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown