MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 14G X 5.25IN (2.1 X 133 MM) ANGIOCATH SPECIAL; INTERVASCULAR CATHETER

Catalog Number	382269
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: production markets production operations (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 the 14g x 5.25in (2.1 x 133 mm) angiocath special experienced no label or missing label information which was noted prior to use.The following information was provided by the initial reporter: material no.: 382269, batch no.: 9204248.Per email: while receiving we discovered 1 cs is missing the label identifying the lot and expiration.
Event or Problem Description
It was reported that the 14g x 5.25in (2.1 x 133 mm) angiocath special experienced no label or missing label information which was noted prior to use.The following information was provided by the initial reporter: material no.: 382269, batch no.: 9204248.Per email: while receiving we discovered 1 cs is missing the label identifying the lot and expiration.
Additional Manufacturer Narrative
H.6.Investigation summary: a device history review was conducted for lot number 9204248 our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Based on their evaluation of the provided photos, our quality engineers have determined that the most likely root cause is human error during the labeling of the shipping box.To address this we have conducted a retraining of packaging personnel.H3 other text : see section h.10.

• Brand Name: 14G X 5.25IN (2.1 X 133 MM) ANGIOCATH SPECIAL
• Common Device Name: INTERVASCULAR 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: 9257222
• Report Number: 9610847-2019-00655
• Device Sequence Number: 13986559
• Product Code: FOZ
• UDI-Device Identifier: 30382903822691
• UDI-Public: 30382903822691
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: 07/31/2024
• Device Catalogue Number: 382269
• Device Lot Number: 9204248
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/09/2019
• 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