MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION SET (C50)

Catalog Number 515300

Device Problems Leak/Splash (1354); Delivered as Unsterile Product (1421)

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

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

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 there was a missing connector with a bd phaseal¿ infusion set (c50) before use.The following information was provided by the initial reporter, "connector part was not in the packaging.".

Event Description

It was reported that there was a missing connector with a bd phaseal¿ infusion set (c50) before use.The following information was provided by the initial reporter, "connector part was not in the packaging.".

Manufacturer Narrative

The correction is as follows: medical device manufacturer: becton dickinson, s.A.

Manufacturer Narrative

H.6.Investigation summary: one photo was provided to our quality team for investigation.Upon reviewing the photo, it was verified the connector was not attached to the drip chamber.A device history review was performed and found no non-conformances associated with this issue during the production of lot k71646-1.The final product for lot k71646-1 is assembled and packaged at a supplier site.We notified the supplier of the reported issue and provided the photo for evaluation.The assembly of the connector to the chamber is a manual process which is completed prior to assembling the tubing.Through their investigation it was determined that this issue likely occurred as human error.The operator likely overlooked this task and did not properly identify the missing connector before the item was packaged.It is believed this is an isolated incident that is unlikely to reoccur.Complaints received for this device and defect will be continue to be monitored by our quality team for signs of emerging trends.Conclusion(s): the final product secondary set c50 is not assembled/packaged in san agustín facilities.The information of this complaint was sent to the subcontractor (codan) to perform the investigation (sc-058-19).According to their report, the defect seems to be caused by a human error.The assembly of the drip chamber and carmel adapter was a manual process.Apparently, operator overlooked the assembly of the adapter due to a human error.The fault is considered as an isolated case.H3 other text : see section h.10.

Event Description

It was reported that there was a missing connector with a bd phaseal¿ infusion set (c50) before use.The following information was provided by the initial reporter, "connector part was not in the packaging.".

• Brand Name: BD PHASEAL¿ INFUSION SET (C50)
• Type of Device: INFUSION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix UT 84070
• MDR Report Key: 8744128
• MDR Text Key: 149684496
• Report Number: 3003152976-2019-00429
• 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,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2019

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 Expiration Date: 10/28/2020
• Device Catalogue Number: 515300
• Device Lot Number: K71646-1
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 06/13/2019; 06/13/2019
• Supplement Dates FDA Received: 07/11/2019; 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other