MAUDE Adverse Event Report: CAREFUSION GRAVITY SET 60DP CKV 2SMS DEHP FREE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	47233E
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.
Event or Problem Description
It was reported that 1008-000-072 products were received rather than 47233e - gravity set 60dp ckv 2sms dehp free.The following information was provided by the initial reporter: material no: 47233e batch no: unknown.It was reported the customer received the wrong items in the package.Bd acct executive (b)(6) 2020 @7:41 pm: we were supposed to send 47233e.What arrived was 1008-000-072.One box had the right product code on it 47233e, but the contents were 1008-000-072.Bd account exec: (b)(6) 2020 @3:29 pm: customer was in dire need of this product and we sent the wrong product.We did so w/ 2 cases, and 1 case said it was the right product with the wrong item in it.Bd account exec: 21 jul 2020 @ 12:38pm: customer just called very disappointed as they said 3 cases of luer caps arrived, and it appears the wrong product was sent.It was a product # i don¿t see in our catalog, 108000072.Bd acct executive (b)(6) 2020 @12:24 pm: shipment arrived, but two of the cases were the wrong item, and one of the cases has a sticker as though it¿s the right item but has the same luers in the box.
Additional Manufacturer Narrative
A complaint of incorrect product in package was received from the customer.A device history record review could not be performed on model 47233e because a lot number was not provided by the customer.The root cause of this failure was not identified.
Event or Problem Description
It was reported that 1008-000-072 products were received rather than 47233e - gravity set 60dp ckv 2sms dehp free.The following information was provided by the initial reporter: material no: 47233e, batch no: unknown.It was reported the customer received the wrong items in the package.Bd acct executive 21 jul 2020 at 7:41 pm: we were supposed to send 47233e.What arrived was 1008-000-072.One box had the right product code on it 47233e, but the contents were 1008-000-072.Bd account exec: 21 jul 2020 at 3:29 pm: customer was in dire need of this product and we sent the wrong product.We did so w/ 2 cases, and 1 case said it was the right product with the wrong item in it.Bd account exec: 21 jul 2020 at 12:38pm: customer just called very disappointed as they said 3 cases of luer caps arrived, and it appears the wrong product was sent.It was a product # i don¿t see in our catalog, 108000072.Bd acct executive 21 jul 2020 at 12:24 pm: shipment arrived, but two of the cases were the wrong item, and one of the cases has a sticker as though it¿s the right item but has the same luers in the box.

• Brand Name: GRAVITY SET 60DP CKV 2SMS DEHP FREE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10400031
• Report Number: 9616066-2020-02407
• Device Sequence Number: 2938483
• Product Code: FPA
• UDI-Device Identifier: 10885403235443
• UDI-Public: 10885403235443
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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: 47233E
• Device Catalogue Number: 47233E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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