MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK

Catalog Number 395180

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: no picture or samples are available at this point to evaluate the incident.Sample is required to confirm/discard this kind of problem.No sample retention for stopcocks product.Complaint trending review not performed due to the lack of lot number.For product family the issue (leakage) was reported but unconfirmed last time on (b)(6) 2017.No dhr review was developed for material (b)(4) since no lot number was available.This catalog is usually manufactured in equipment (b)(4).Issue previously reported but unconfirmed 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 of confirm the customer¿s indicated failure mode.Customer reported leakage issues; however no sample was available for evaluation which is essential to perform a better investigation.Quality records have been consulted for tracking and trending purposed and no issues like this have been detected which means pretty loss occurrence.Product is functional tested and no incidents with leakages have been reported.Process fmea (b)(4) was reviewed and there are proper controls in place to detect product malfunctions.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.(b)(4).

Event Description

It was reported that during an infusion the bd connecta¿ stopcock was detached and medication leaked out.No injury or medical intervention.

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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: 6850508
• MDR Text Key: 85596472
• Report Number: 9610847-2017-00068
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2017

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 Catalogue Number: 395180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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