MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD IV-EXTENSION TUBE 25 CM PVC L-L; IV SET

Catalog Number 397251

Device Problem Leak/Splash (1354)

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

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Investigation summary: investigation summary: no samples sent/received of iv-extension tube 25 cm pvc l-l catalog 397251 with lot number 6200862.According to issue stated by customer ¿the extension tube is leaky directly on the connection to the nasal tube¿ no sample was received.Review of dhr was performed and issues similar to the one stated by the customer was not found.According to the statement of complaint we cannot confirm the issue stated by the customer and we cannot assign it as a manufacturing defect, this incident will be monitored for future occurrences.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode.No samples were received from customer complaint, we could not confirm the issue stated by the customer.Root cause: we could not determine the root cause and cannot confirm the issue stated by the customer due that no samples or pictures were received.Dhr for lot number 6200862 was reviewed and no issues like the one stated by customer was found.A complaint history check was performed and this is the 2nd related complaint reported for the defect/condition stated by customer.There was no report of serious injury or medical/surgical intervention that occurred as a result of this incident.No corrective action is required at this time.

Event Description

It was reported that the nurse found a leak in the bd iv-extension tube 25 cm pvc l-l directly on the nasal tube.No serious injury or medical intervention noted.

• Brand Name: BD IV-EXTENSION TUBE 25 CM PVC L-L
• Type of Device: IV SET
• 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: 7076267
• MDR Text Key: 94546796
• Report Number: 9610847-2017-00162
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 397251
• Device Lot Number: 6200862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• 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