MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number	42521E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that gra 15dp ckv 3ss w/2 4w stpck dehp free disconnected and lost blood.The following information was provided by the initial reporter: material no: 42521e batch no: unknown.It was reported that a gravity set became disconnected when a patient was being transferred, resulting in blood product lost.Dr.(b)(6) has just informed me of another incident with bd gravity set.When transporting the patient over to the pacu, gravity set became disconnected and as a result, blood product was lost.She has informed me of 3 different instances of patient care concerns due to poor quality of product.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint of gravity set disconnection could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review could not be performed on model 42521e because a lot number was not provided by the customer.
Event or Problem Description
It was reported that gra 15dp ckv 3ss w/2 4w stpck dehp free disconnected and lost blood.The following information was provided by the initial reporter: material no: 42521e batch no: unknown.It was reported that a gravity set became disconnected when a patient was being transfered, resulting in blood product lost.Dr.Xxxx has just informed me of another incident with bd gravity set.When transporting the patient over to the pacu, gravity set became disconnected and as a result, blood product was lost.She has informed me of 3 different instances of patient care concerns due to poor quality of product.

• Brand Name: GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10775341
• Report Number: 9616066-2020-20238
• Device Sequence Number: 3884090
• Product Code: FPA
• UDI-Device Identifier: 50885403274259
• UDI-Public: 50885403274259
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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 Model Number: 42521E
• Device Catalogue Number: 42521E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1