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 Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set octopus piece broke and caused prostin to leak out.The following information was provided by the initial reporter, translated from (b)(6) to english: "octopus piece broken off in orange lumen of cl causing leakage of prostin." "did the defect affect a patient? more or less.The medication (prostin) that was running had to be doubled.The question is whether this had to be done anyway or whether it was due to the leakage of the infusion.".
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set octopus piece broke and caused prostin to leak out.The following information was provided by the initial reporter, translated from (b)(6) to english: "octopus piece broken off in orange lumen of cl causing leakage of prostin." "did the defect affect a patient? more or less.The medication (prostin) that was running had to be doubled.The question is whether this had to be done anyway or whether it was due to the leakage of the infusion.".
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set octopus piece broke and caused prostin to leak out.The following information was provided by the initial reporter, translated from dutch to english: "octopus piece broken off in orange lumen of cl causing leakage of prostin." "did the defect affect a patient? more or less.The medication (prostin) that was running had to be doubled.The question is whether this had to be done anyway or whether it was due to the leakage of the infusion.".
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the 3 photos submitted for evaluation.The reported issue of component damage ¿ leak was not confirmed since a physical sample is required to confirm the reported defect.The supplied photos were examined, and it could be seen that there is breakage at the male connection site of the product.The breakage seen in the photo is commonly caused when excess force is applied to the product.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review was not performed since no batch number was reported.H3 other text : see h10.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12923373
• Report Number: 9610847-2021-00580
• Device Sequence Number: 5737311
• Product Code: FPA
• UDI-Device Identifier: 50382903851633
• UDI-Public: 50382903851633
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 01/18/2022

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
• Operator of Device: Other
• Device Model Number: 385163
• Device Catalogue Number: 385163
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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