MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 WHITE PEGS

Catalog Number 394601

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown (b)(4).

Event Description

It was reported that connecta plus3 white pegs leaked during connection.The following information was provided by the initial reporter: bd connecta has a leakage during the connection.

Event Description

It was reported that connecta plus3 white pegs leaked during connection.The following information was provided by the initial reporter: bd connecta has a leakage during the connection.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-10-26.H6: investigation summary: a device history record review was performed for provided lot number 9218064 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, the physical sample was returned for evaluation by our quality engineer team.The sample was visually inspected and no signs of cracks or any other damage were found on the product.Due to current preventive safety measures related to covid-19 within the investigative facility, the sample was not handled further than visual inspection.Our quality records for this product and issue have been consulted and it appears that this was an isolated incident with a low occurrence.Based on the investigation results, an exact cause related to the manufacturing facility could not be identified for this issue.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.

• Brand Name: CONNECTA PLUS3 WHITE PEGS
• Type of Device: CONNECTA
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10544736
• MDR Text Key: 208805937
• Report Number: 9610847-2020-00285
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other