MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number 385100

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2020

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.(b)(4).

Event Description

It was reported that hair-like foreign matter was found in the packaging of the bd q-syte¿ luer access split-septum stand-alone device before it was opened.The following information was provided by the initial reporter, translated from (b)(6) to english: "the clinical client reported to the armory department that before the package of q-syte was opened, there was the foreign matter which was suspected hair in the package".

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 9031813 and the review did not reveal any detected quality issues during the production process that could have contributed to this incident.To aid in the investigation of this issue, two picture samples were received for evaluation by our quality engineer team.Through examination of the picture samples, a hair was observed within the unopened product packaging.Our quality team inspected the production process with the intention of identifying a possible cause for this incident; however, no abnormalities related to the production equipment, the employee gowning requirements, or the cleaning process were detected.It has been determined that this incident resulted from improper detection of faulty product during the inspection process.Based on the current cleaning procedures and 100% inspection plan, we believe this issue has a low chance of recurrence.In response to this incident, a notification was sent to the manufacturing personnel to increase the focus on the segregation of defective product.

Event Description

It was reported that hair-like foreign matter was found in the packaging of the bd q-syte¿ luer access split-septum stand-alone device before it was opened.The following information was provided by the initial reporter, translated from chinese to english: "the clinical client reported to the armory department that before the package of q-syte was opened, there was the foreign matter which was suspected hair in the package".

• Brand Name: BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10114463
• MDR Text Key: 195432004
• Report Number: 9610847-2020-00167
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: 30382903851004
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: 9031813
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 05/14/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other