MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SECONDARY SET C62; N/A

Catalog Number 515312

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that secondary set c62 tubing was kinked.This was discovered during use.The following information was provided by the initial reporter: c62 kinked tube.The c62 secondary set is kinked at the portion where the clip is.When the pharmacist removed the item from packaging and undo the clip to prime with saline, the tube is kinked and would not recover, thus obstructing flow.Sample contaminated with saline.

Manufacturer Narrative

H.6.Investigation summary: one sample was provided to our quality team for investigation.The final product for lot ta11606 is assembled and packaged at a supplier site.We notified the supplier of the reported issue and provided the product for evaluation.Upon visually inspecting the sample that was received, the tubing was observed to be kinked where the clamp was placed.Functional evaluations were conducted, priming the set with saline, no issues were identified and no flow obstruction occurred.A device history review was performed and found no non-conformances associated with this issue during the production of lot ta11606.All testing was reviewed for the reported lot, including leakage, torque, and inspection results with no issues identified related to the reported malfunction, product was manufactured according to specifications.Based on the investigation, it was determined personnel is considered to be the root cause of this incident.The operator likely activated the clamp for leakage testing and did not properly deactivate the clamp once complete.The supplier is looking further into this issue to properly address.Complaints for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see section h.10.

Event Description

It was reported that secondary set c62 tubing was kinked.This was discovered during use.The following information was provided by the initial reporter: c62 kinked tube.The c62 secondary set is kinked at the portion where the clip is.When the pharmacist removed the item from packaging and undo the clip to prime with saline, the tube is kinked and would not recover, thus obstructing flow.Sample contaminated with saline.

• Brand Name: SECONDARY SET C62
• Type of Device: N/A
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9370559
• MDR Text Key: 191156110
• Report Number: 3003152976-2019-00806
• Device Sequence Number: 1
• Product Code: FPA
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 515312
• Device Lot Number: TA11606
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other