MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ EXTENSION TUBE; IV SET

Catalog Number 397251

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2017

Event Type  malfunction  

Manufacturer Narrative

No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd connecta¿ extension tube was leaking during use.There was no report of exposure, injury or medical interventions.

Manufacturer Narrative

No samples were received from the customer and a lot number was not provided, therefore we were unable to perform a dhr review and we cannot confirm the issue stated by the customer.Without a sample, an absolute root cause for this incident cannot be determined.

• Brand Name: BD CONNECTA¿ EXTENSION TUBE
• 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: 7014744
• MDR Text Key: 92680394
• Report Number: 9610847-2017-00148
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K974083
• 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
• Report Date: 11/28/2017

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: 397251
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 11/29/2017
• 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