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

Catalog Number 385100

Device Problems Break (1069); Occlusion Within Device (1423); Split (2537)

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

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

No lot # provided.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 a bd q-syte luer access split septum stand-alone device the central venous pressure measurement indicated occlusion.Research shows that the q-syte was broken.This was found during use.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: our quality engineer inspected the samples provided by the facility.We received two used q-syte units.It was observed that unit #1 was connected to a three way miscellaneous valve with a connector attached.Unit #2 was received with the q-syte top body inside (connected) to a male end of an extension set and the bottom body was separated.The visual/microscopic examination for unit #1 showed that the top body of the q-syte was broken inside the white connector and it was only being held by the q-syte¿s septum.Severe breakage/stress was observed at the separation area.For unit #2 it was observed to be a complete separation between the neck (female connection site) and the rest of the body; the q-syte¿s neck and septum stayed inside of the male luer connection of the extension set.Traces of unknown solution around the threads on the male connector were also observed as well as severe breakage/stress at the separation.Confirmation of the defect stated in the reported issue was confirmed.Both of the units received revealed separation (complete or partial) between the q-syte neck and the rest of the body as well as severe breakage/stress at the separation area.A device history record review could not be performed as the lot number is unknown.Even though confirmation of the defect stated in the reported issue was confirmed, the root cause could not be determined.Event description: central venous pressure measurement indicated occlusion.Research shows that the q-syte was broken (thus, it was not broken during unscrewing but is spontaneously broken during use.) q-syte used on this patient came from the cvk (central venous catheter) kit from medline (made in (b)(4)).Lot analysis device/batch history record review: no.Reason: dhr¿s are available for reviews as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable.Although this incident is mdr the lot number was unknown therefore review could not be performed.Findings: n/a visual analysis observations and testing: received 2 used q-syte units as follows ((b)(4)): unit 1: the unit was connected to a three way miscellaneous valve with a connector attached.Unit 2: the unit was received with the q-syte top body inside (connected) to a male end of an extension set and the bottom body separated.Visual/microscopic examination: unit 1: observed the top body of the q-syte broken up inside the white connector and was only being held by the q-syte¿s septum.Severe breakage-stress was observed at the separation area ((b)(4)) unit 2: observed a complete separation between neck (female connection site) and the rest of the body; the q-syte¿s neck and septum stayed inside of the male luer connection of the extension set.Observed traces of unknown solution around the threads on the male connector as well as severe breakage-stress at the separation ((b)(4)).Test description : visual/microscopic.Method no: n/a, results: see observations and testing investigation samples(s) meet manufacturing specifications: no, both of the units received revealed separation (complete or partial) between the q-syte neck and the rest of the body.Investigation conclusion: both of the units received revealed separation (complete or partial) between the q-syte neck and the rest of the body as well as severe breakage/stress at the separation area.The q-syte neck separation from the body was most likely introduced by external forces.A definite cause that contributed to the separation of the q-syte¿s neck from the remainder of the body could not be determined.Prolonged contact with incompatible medications or cleaning solutions may have contributed to the damage.A definite cause cannot be assigned at this time.The damage identified could be introduced due to incorrect usage.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: LEUR ACCESS SPLIT-SEPTUM
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 6947074
• MDR Text Key: 90320792
• Report Number: 9610847-2017-00115
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K013621
• 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: 01/17/2018

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 Catalogue Number: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 09/25/2017
• Supplement Dates FDA Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other