MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ TRI-EXTENSION SET 15 CM (6 IN) 2.25 ML

Catalog Number	385162
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd q-syte¿ tri-extension set 15 cm (6 in) 2.25 ml had broken valves.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd q-syte¿ tri-extension set 15 cm (6 in) 2.25 ml had broken valves.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: three samples were received in support of this complaint.The samples received showing the reported defect.Based on the description received, the broken connector is not caused in the nogales manufacturing process.The failure mode can¿t be reproduced in the current manufacturing process and the failure mode can¿t be confirmed.The reported luer connector end is not used in the process.No findings in qns/ncmr/dhr about the lot number 7209508 was found.This is considered as an isolated issue.Investigation conclusion: some plastic materials may be affected by chemicals such as alcohol that might cause some dryness on the parts and potentially being damaged when applied an excessive pressure when connected.No chemicals are used in the nogales manufacturing process.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

• Brand Name: BD Q-SYTE¿ TRI-EXTENSION SET 15 CM (6 IN) 2.25 ML
• Common Device Name: Q-SYTE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7757240
• Report Number: 9610847-2018-00251
• Device Sequence Number: 11201898
• Product Code: FPA
• UDI-Device Identifier: 00382903851621
• UDI-Public: 00382903851621
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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
• Operator of Device: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 385162
• Device Lot Number: 7209508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other