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 Problems Partial Blockage (1065); Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that an unspecified bd q-syte was clogged and was damaged, but still operable.The following information was provided by the initial reporter: "it seems that the membranes in the q-syte partly dissolve into a slimy substance which attaches itself to the connector of the perfusion line but also closes it off so that the administration stagnates.".

Manufacturer Narrative

The following fields were updated due to additional information: b.5.Describe event or problem: it was reported that an bd q-syte¿ luer access split-septum stand-alone device was clogged and was damaged, but still operable.The following information was provided by the initial reporter: "it seems that the membranes in the q-syte partly dissolve into a slimy substance (see photo) which attaches itself to the connector of the perfusion line but also closes it off so that the administration stagnates." d.1.Medical device brand name: bd q-syte¿ luer access split-septum stand-alone device; d.2.Medical device type: fpa; d.2.Common device name: intravascular administration set; d.3.Medical device manufacturer: bd infusion therapy systems inc.S.A.De c.V.(nogales); d.4.Medical device catalog #: 385100; d.4.Medical device lot #: 1053552; d.4.Medical device expiration date: 31-jan-2026; d.4.Unique identifier (udi) #: (b)(4); d.9.Device available for eval?: yes; d.9.Returned to manufacturer on: 04-feb-2022; g.1.Manufacturing location: bd infusion therapy systems inc.S.A.De c.V.(nogales); g.4.Pma / 510(k)#: k013621; h.4.Device manufacture date: 05-mar-2021.H.6.Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one q-syte device connected to an extension set along with an opened empty package from lot number 1053552.In addition, two photos were received.Upon inspection of the photos and the received device it was identified that the q-syte has been severely damaged.The extension set luer is visible through the septum and q-syte top body.It was identified that the septum column wall has a large hole in it and the neck of the top body has completely separated from the rest of the top body.The neck of the top body is present within the extension set connector.The device was removed from the extension set and the q-syte was microscopically inspected along the top body and cracked neck.Rough edges were observed around the entire device and no direct indicators of impact were observed.It was also identified that part of the top body has cracked away and lifted.Although component damage was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.Even though septum and top body can potentially be damaged during the assembly, the extent of the damage seen in the returned sample has not been historically observed in the manufacturing defects.Outside of the manufacturing process the damage may have originated from over torquing the q-syte or from incompatibility with the infusion fluids.Compatibility of propofol with the q-syte was approved.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

Event Description

It was reported that an bd q-syte¿ luer access split-septum stand-alone device was clogged and was damaged, but still operable.The following information was provided by the initial reporter: "it seems that the membranes in the q-syte partly dissolve into a slimy substance (see photo) which attaches itself to the connector of the perfusion line but also closes it off so that the administration stagnates.".

• 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 NJ ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales NJ ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13181412
• MDR Text Key: 286658775
• Report Number: 2243072-2021-03045
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: 30382903851004
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

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: Other
• Device Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: 1053552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2021
• 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