MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SITE W/ STANDARD BORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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¿ luer access site w/ standard bore extension set tubing was defective.This was discovered during use.The following information was provided by the initial reporter: we have at medical imaging a problem with the bd q-syte extension set at the level of the clamp.This reference can be found in a number of departments, but it is only from medical imaging that i get a complaint.Blistering occurs at the position where the clamp has been stuck.
Additional Manufacturer Narrative
H.6.Investigation: one picture sample was received for evaluation by our quality engineer team.Through examination of the provided picture, the tubing was observed damaged.Based on the conditions of the product in the picture, it is possible that excessive pressure during use resulted in the tubing damage.A device history record review was performed for the provided lot number and the review did not reveal any signs of non-conformance during the production process.The extension set is received from a supplier company.Based on the investigation results, an exact cause could not be determined for this incident.
Event or Problem Description
It was reported that bd q-syte¿ luer access site w/ standard bore extension set tubing was defective.This was discovered during use.The following information was provided by the initial reporter: we have at medical imaging a problem with the bd q-syte extension set at the level of the clamp.This reference can be found in a number of departments, but it is only from medical imaging that i get a complaint.Blistering occurs at the position where the clamp has been stuck.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SITE W/ STANDARD BORE 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
• MDR Report Key: 9284417
• Report Number: 9610847-2019-00665
• Device Sequence Number: 2525390
• Product Code: FPA
• UDI-Device Identifier: 30382903851011
• UDI-Public: 30382903851011
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 09/30/2023
• Device Catalogue Number: 385101
• Device Lot Number: 8351593
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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