MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ANGIOCATH¿ 16 G X 1.88 IN INTRAVASCULAR CATHETER

Catalog Number 388330

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: samples/ photos: according to the visual analysis of the photos, it was not possible to confirm the complaint. For this product catalog the date of manufacture and the batch are stamped on the film and the expiration date on the blister is printed on the back of the packaging, ie on the top web containing the following description: "expiration date: 5 years after manufacturing". Investigation conclusion: not confirmed: bd was unable to confirm this complaint. Investigation comments: this complaint could not be confirmed as the expiration date is on the back of the packaging, printed on the paper containing the words: "expiration date: 5 years after manufacturing" and the manufacturing date is stamped on the film, as on the photos of the claimed samples. In addition, this date format for this type of catalog (national angiocath) is contained in internal document (b)(4). Based on the analysis of the photos, no root cause was assigned to this incident, since the complaint was not confirmed. Rationale: based on a severity assessment and occurrence it was determined that no capa is required at this time. The complaint was added to the complaint database for trend analysis, which is regularly monitored. Dhr review: device history record analysis was not performed since due to the analysis of the photos it was not a manufacturing failure of the manufacturing of the product.

Manufacturer Narrative

A sample is not available for evaluation. Customer photos were submitted. However, a no sample investigation and device history record review will be completed. Upon completion of the investigation, a supplemental report will be filed. Udi#: (b)(4).

Event Description

It was reported that a gynecological nurse noticed the blister information on a bd angiocath¿ 16 g x 1. 88 in contained only the manufacturing date but not the expiration date. The missing information was found post use. There was no injury or medical intervention reported.

• Brand Name: BD ANGIOCATH¿ 16 G X 1.88 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6843594
• MDR Text Key: 253853584
• Report Number: 9610048-2017-00021
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K950301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 388330
• Device Lot Number: 5065173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/05/2017 Patient Sequence Number: 1