MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA ¿ 3-WAY TAP, BLUE, 10CM HOSE; STOPCOCK

Catalog Number 39997

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a black foreign matter was found on a bd connecta ¿ 3-way tap, blue, 10cm hose before use.No injury or medical intervention.

Manufacturer Narrative

Investigation: lot number / product family history: complaint trending review of this lot and issue reveals no other complaint.For product family the issue (foreign matter) was reported last time on (b)(6) 2017.Dhr/bhr review: material 394997 with lot number 7094824 was manufactured on apr-23-2016 by equipment ka71.No qn's or other extraordinary events have been related to the complaint.No issues detected from manufacturing process, maintenance or calibrated instruments.Issue previously reported for associated stopcocks product family.The complaint rate remains at historical levels as observed on records.No trending observed.Bd was not able to duplicate or confirm the customer¿s indicated failure mode.Customer reported foreign material issues; however no sample was available at this point which is essential to perform a better investigation.Quality records have been consulted for tracking and trending purposes and no issues like this are detected which means pretty low occurrence.Control plan hbg-005sp requires to execute suitable controls to detect foreign material during the manufacturing of a product lot.Process fmea was not intentionally mentioned because failure mode reported isn't equipment related.Always refer to ifu for product usage recommendations.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.Root cause based on investigation results to date, root cause for manufacturing process cannot be determined.

Manufacturer Narrative

Correction: medical device catalog #: 394997.

Manufacturer Narrative

Investigation summary: complaint noted ¿lumen is dirty (black, looks like oil or grease).Customer thought it was mold¿ six samples were sent with the complaint.Upon review only one part contained the black specks.This part had multiple small black specks embedded in the stopcock housing.The black specks are degraded plastic material, not oil or grease.During the molding process, the plastic resin, polycarbonate, can burn and get stuck onto the screw of the molding press or in the manifold of the mold.It can break loose and cause a black specks in the parts.Investigation conclusion: the black speck condition is molding related and inherent in the process.Root cause description: the black speck condition is molding related and inherent in the process.

• Brand Name: BD CONNECTA ¿ 3-WAY TAP, BLUE, 10CM HOSE
• Type of Device: STOPCOCK
• 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: 6805423
• MDR Text Key: 83199515
• Report Number: 9610847-2017-00057
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2017

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
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 39997
• Device Lot Number: 7094824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 07/25/2017; 07/25/2017; 07/25/2017
• Supplement Dates FDA Received: 09/13/2017; 09/27/2017; 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other