MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C62); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515312

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: two photos were provided to our quality team for investigation.The final product for lot ta11878 is assembled and packaged at a supplier site.Upon visual inspection, no protective cap was observed on the end of the luer connection, verifying the reported incident.Five retained samples were used for additional evaluation, there were no defects noted, all protective caps were properly in place, and product was manufactured according to specification.Product undergoes inspections throughout manufacturing, inspection results were reviewed for the reported lot with no issues identified related to the reported malfunction.Based on available information, we were not able to identify a definitive root cause related to the manufacturing process at this time.Investigation conclusion: the final product secondary set c62 is not assembled/packaged in (b)(4) facilities.The information of this complaint was sent to the subcontractor (sendal) to perform the investigation (sc-047-20).According to their report rc-2020-131 (received on april 22nd, 2020), after the investigation, the dhr review (no issues detected during production) and the complaint trend history (not related complaints), it is concluded that it is not possible to determine the root cause with accuracy.Note that the issue was detected after opening the packaging, so it is possible that the protective cap was missing between the opening and the use of the set.Furthermore, five samples retained in bd (b)(4) facilities were subjected to visual inspection.The visual inspection on unused samples retained at bd (b)(4) facilities cannot replicate the issue detected by the customer as the protective cap was in place.The complaint trend history was review for a one-year period and several additional complaints were found related to the affected reference c62.Consider the current complaint is the first one related to a missing protective cap root cause description: after the investigation, the dhr review (no issues detected during production) and the complaint trend history (not related complaints), it is concluded that it is not possible to determine the root cause with accuracy.Note that the issue was detected after opening the packaging, so it is possible that the protective cap was missing between the opening and the use of the set.Furthermore, five samples retained in bd (b)(4) facilities were subjected to visual inspection.The visual inspection on unused samples retained at bd (b)(4) facilities cannot replicate the issue detected by the customer as the protective cap was in place.Rationale: capa is not required in this instance as the issue could not be replicated without sample, without evidences after the dhr review and after visual inspection of the retained samples.

Event Description

It was reported that the bd phaseal¿ secondary set (c62) was missing its protective cap before use.The following information was provided by the initial reporter: "c62 missing protective cap.After opening the c62 from packaging, the pharmacist noticed that the protective cap at the end of the luer connection is missing.".

• Brand Name: BD PHASEAL SECONDARY SET (C62)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10083076
• MDR Text Key: 212147401
• Report Number: 3003152976-2020-00221
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 515312
• Device Lot Number: TA11878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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