MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	382268
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6). a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter was found in the fluid path of a bd angiocath¿ iv catheter prior to use.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that foreign matter was found in the fluid path of a bd angiocath iv catheter prior to use.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Bd was able to confirm the customer¿s indicated failure mode.Based on pictures provided the reported failure mode was confirmed.The engineering team associated the reported foreign material to our packaging process.Quality records have been consulted for tracking and trending purposes and this is the first incident reported.Procedures pg-089sp requires to execute suitable controls to detect foreign material during the packaging of a product lot.Process fmea was not intentionally mentioned because failure mode reported isn¿t equipment related.A complaint history check was not performed as the lot number is "unknown" for this complaint.Investigation conclusion: based on investigation results to date, root cause could be associated to packaging process.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture.
Event or Problem Description
It was reported that foreign matter was found in the fluid path of a bd angiocath iv catheter prior to use.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• 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
• MDR Report Key: 7638817
• Report Number: 9610847-2018-00168
• Device Sequence Number: 2435846
• Product Code: FOZ
• UDI-Device Identifier: 30382903822684
• UDI-Public: 30382903822684
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2018

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 Catalogue Number: 382268
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 06/01/2018; 06/01/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/24/2018; 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other