MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ BI-EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	385163
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set broke inside the hickmann catheter during use and was removed with a wrench.The following information was provided by the initial reporter: "on friday (b)(6) we had two children with a hickmann catheter.In both cases the connected infusion system broke inside the hickmann catheter.In one case, the surgeon was able to remove the part using a wrench.".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-feb-2023 h6: investigation summary our quality engineer inspected the 1 sample and 1 photo submitted for evaluation.The reported issue of connection issue was not confirmed upon inspection of the sample.Analysis of the sample showed that there were no abnormalities or damages on the sample.The sample was functionally tested and performed without issue.Bd cannot determine a manufacturing related root cause since the reported defect was not confirmed during the sample evaluation.Production records were reviewed, and this batch met our manufacturing product specification requirements.See h10.
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set broke inside the hickmann catheter during use and was removed with a wrench.The following information was provided by the initial reporter: "on friday 13.01 we had two children with a hickmann catheter.In both cases the connected infusion system broke inside the hickmann catheter.In one case, the surgeon was able to remove the part using a wrench".
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set broke inside the hickmann catheter during use and was difficult to remove, having to be cut and renewed with a repair set.The following information was provided by the initial reporter: "on friday 13.01 we had two children with a hickmann catheter.In both cases the connected infusion system broke inside the hickmann catheter.In the second case the hichmann catheter had to be cut and renewed with a repair set, which was a lot of work.".
Additional Manufacturer Narrative
Correction: the following was corrected with new investigation.Imdrf annex c grid: c23 imdrf annex d grid: d11 h6: investigation summary our quality engineer inspected the 1 photo and 1 sample submitted for evaluation.The reported issue of component damage - no leak was confirmed upon inspection of the sample.Analysis of the sample showed that there was damage to the fitting connector.Our manufacturing processes were reviewed, and none were determined to be able to cause the damages observed.Bd determined that the cause of the failure was most likely attributed to excessive force being applied during use of the product.Per the returned photo the sample was used which means the device was able to be connected to another device.Excessive force was most likely applied to the product during the connection process, causing the observed damages.Production records were reviewed, and this batch met our manufacturing product specification requirements.

• Brand Name: BD Q-SYTE¿ BI-EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16330782
• Report Number: 9610847-2023-00020
• Device Sequence Number: 17851295
• Product Code: FPA
• UDI-Device Identifier: 00382903851638
• UDI-Public: 00382903851638
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 385163
• Device Catalogue Number: 385163
• Device Lot Number: 2060364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 04/21/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/30/2023; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown