MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANGIOCATH SPECIAL ORN 14GA X 3.25IN; INTRAVASCULAR CATHETER

Catalog Number	382268
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 angiocath special orn 14ga x 3.25in needle went through the cover.The following information was provided by the initial reporter: it was reported the sleeve does not protect the needle or its tip.
Event or Problem Description
It was reported that angiocath special orn 14ga x 3.25in needle went through the cover.The following information was provided by the initial reporter: it was reported the sleeve does not protect the needle or its tip.
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the three photos submitted for evaluation.The reported issue was confirmed upon inspection of the photos.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Damage to the device could have more easily occurred during use since the product was seven years past its expiration date, but this cause can not be confirmed.A device history record review could not be performed since device history records are disposed of after seven years from the lot creation date, this lot was produced in 2007.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.See h.10.

• Brand Name: ANGIOCATH SPECIAL ORN 14GA X 3.25IN
• 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
• MDR Report Key: 12408072
• Report Number: 9610847-2021-00413
• Device Sequence Number: 3549525
• Product Code: FOZ
• UDI-Device Identifier: 00382903822683
• UDI-Public: 00382903822683
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 04/30/2012
• Device Catalogue Number: 382268
• Device Lot Number: 7093870
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1