MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ PLUS3 WHITE BLEND OEM; STOPCOCK

Catalog Number 395214

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: n/a.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that there were 500 occurrences of foreign matter bd connecta¿ plus3 white blend oem.The following information was provided by the initial reporter: smears on the products.Goggle translation: the sample of the person who entered a small bag has all the dirt (foreign matter), and it was confirmed that the large bag is attached to a large number of samples from the outside of the bag.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8184947.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.Bd quality engineers were able to confirm the reported failure mode; composition testing of the foreign material present on the device determined that it is mainly composed of iron and aluminum.This suggests that origins of the material are most likely with the manufacturing machinery.A thorough review of the manufacturing line was unable to identify the specific station that produced this non-conformance.Unfortunately without being able to identify the origin of the foreign material, the root cause for this complaint could not be finalized at the conclusion of our review.

Event Description

It was reported that there were 500 occurrences of foreign matter bd connecta¿ plus3 white blend oem.The following information was provided by the initial reporter: smears on the products.Google translation: the sample of the person who entered a small bag has all the dirt (foreign matter), and it was confirmed that the large bag is attached to a large number of samples from the outside of the bag.

• Brand Name: BD CONNECTA¿ PLUS3 WHITE BLEND OEM
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8470193
• MDR Text Key: 141063596
• Report Number: 9610847-2019-00257
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395214
• Device Lot Number: 8184947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other