MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ PLUS STOPCOCK WITH EXTENSION LINE; STOP COCK

Catalog Number 394995

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/12/2017

Event Type  Injury  

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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 6039648, medical device expiration date: 01/31/2019, device manufacture date: 03/02/2016.Medical device lot #: 5331898, medical device expiration date: 10/31/2019, device manufacture date: 12/09/2015.Investigation summary return samples required? yes, but need actual sample.Return sample showed: photo showed reported defect.Returned material showed reported defect.Return samples received? no physical samples at this time to evaluate.Dhr: complaint trending review of these lots and issue reveals no other complaint.For product family, there is no previous incidents reported for ¿infection¿.Manufacturing review: no issues detected from manufacturing process, maintenance or calibrated instruments.No previous incidents reported for associated stopcocks product family.Conclusion: unconfirmed: bd was not able to duplicate or confirm the customers¿ indicated failure mode.Based on dhr review for materials reported, all samples taken during the manufacturing of product lots in question were tested against functional and visual inspection and they properly met the acceptance criteria.No rejects issued on these two lots.Product was properly released to market as this showed acceptable pyrogen and sterility results.Sample not available for evaluation which is essential to perform a better investigation.Process fmea¿s (b)(4) were reviewed and there are proper controls in place to detect product and package malfunctions.Root cause: based on investigation results to date, root cause for manufacturing process cannot be determined.Capa determination results: no ¿ based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.

Event Description

It was reported, the.Facility has had an increased amount of infection within the past six months.They are investigating batches of multiple products as well as the product bd connecta plus3 10 cm white.Found during use.Serious injury.No other medical interventions noted.

Manufacturer Narrative

The mdr number (b)(6) was used in the catalog spot.Updated and corrected with the correct catalog number 394995.

• Brand Name: BD CONNECTA¿ PLUS STOPCOCK WITH EXTENSION LINE
• Type of Device: STOP COCK
• 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: 6932808
• MDR Text Key: 89118383
• Report Number: 9610847-2017-00099
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 394995
• Device Lot Number: SEE H.10.
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• 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