MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. GEM 20DP NO PORTS 0.2MF; INTRAVASCULAR ADMINISTRATION SET

Model Number	11612593
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified number of gem 20dp no ports 0.2mf experienced defective/damaged tubing clamps and loose tubing clamps.The following information was provided by the initial reporter: when rn opened the package for the tubing, the clamp roller fell out on the floor.Upon closer inspection, the top piece of the clamp was broken, allowing the roller to fall out customer response to information request 15 jun 2020: was there any patient involvement? no.Was anyone injured and were any interventions needed? no.
Additional Manufacturer Narrative
The following fields were updated due to additional information: udi # d4: (b)(4).D4: catalog # 11612593.D4: medical device lot #: 18035255.D4: medical device expiration date: 03/05/2021 d10: device available for eval yes, d10: returned to manufacturer on: 06/26/2020 h4: device manufacture date:03/05/2018.Investigation conclusion it was reported the top piece of the roller clamp appeared to be broken and the roller fell out.Received from the customer is one used primary set model 11612593 lot 18035255.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection confirmed that the top of the roller clamp (p/n 12281061) was broken and that the roller had fallen out.No tool marks or scratch marks were observed on the roller clamp.No further testing was performed as the customer¿s report was confirmed.Bd tijuana manufacturing has been notified of this issue and has issued a memo notification.A device history record for model 11612593 with lot number 18035255 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 05mar2018.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The customer¿s report that the top piece of the roller clamp appeared to be broken and the roller fell out was confirmed.The root cause of the customer¿s report could not be definitively determined.
Event or Problem Description
It was reported that an unspecified number of gem 20dp no ports 0.2mf experienced defective/damaged tubing clamps and loose tubing clamps.The following information was provided by the initial reporter: when rn opened the package for the tubing, the clamp roller fell out.On the floor.Upon closer inspection, the top piece of the clamp was broken, allowing the roller to fall out customer response to information request 15 jun 2020: ¿ was there any patient involvement? no.¿ was anyone injured and were any interventions needed? no.

• Brand Name: GEM 20DP NO PORTS 0.2MF
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10216200
• Report Number: 9616066-2020-02058
• Device Sequence Number: 3233699
• Product Code: FPA
• UDI-Device Identifier: 50885403283961
• UDI-Public: 50885403283961
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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 Expiration Date: 03/05/2021
• Device Model Number: 11612593
• Device Catalogue Number: 11612593
• Device Lot Number: 18035255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 20200518
• Outcome Attributed to Adverse Event: Other