MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SECONDARY SET C61; ADMINISTRATION SET

Catalog Number 515302

Device Problem Unintended Ejection (1234)

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

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd¿ secondary set c61 had leakage at the junction between set and needle.Customer¿s verbatim: ¿ leakage at junction between infusion set and needle.¿.

Manufacturer Narrative

The following fields were updated due to additional information: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1011186.Medical device expiration date: 2022-04-30.Device manufacture date: 2019-01-31.Medical device lot #: 1011464.Medical device expiration date: 2022-08-31.Device manufacture date: 2018-09-01.

Event Description

It was reported that bd¿ secondary set c61 had leakage at the junction between set and needle.Customer¿s verbatim: ¿leakage at junction between infusion set and needle¿.

Manufacturer Narrative

Investigation: dhr review was done and no issues were reported during production of this lots.2 sample received for this complaint (lot : 1011464) 1 in original packaging and one in used condition still attached to nacl bag decontaminated.2 samples both from lot 1011464 were tested and one in original packaging passed all tests one in used condition was leaking at spike-tube joint.Ct scan was done on leaking sample which was segregated during production.After this scan additional tests were done on spike component and concentricity of lower part of spike component cause molding deficit on one side of component.Capa#891423 was initiated.

Event Description

It was reported that bd¿ secondary set c61 had leakage at the junction between set and needle.¿ leakage at junction between infusion set and needle¿.

• Brand Name: BD¿ SECONDARY SET C61
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8438345
• MDR Text Key: 139444235
• Report Number: 2243072-2019-00530
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 515302
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other