MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRAV SET 20DP V/NV W/CKV 3SS 104-IN; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	42493E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20065512, medical device expiration date: 2023-06-04, device manufacture date: 2020-06-03.Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 2 grav set 20dp v/nv w/ckv 3ss 104-in experienced component separation.The following information was provided by the initial reporter: event 1: it was reported that the iv tubing set was incomplete and missing the end piece.Event 2: it was reported that the iv tubing set was incomplete and missing the end piece.I was onsite at the user facility - same day surgery - for some piv follow-up.While i was there, a team lead approached me about issues with the carefusion iv tubing that they use for surgery.She had two incidences of faulty iv tubing.Both sets were incomplete, without the end piece attached.She does still have those faulty sets and the packages they came in.
Event or Problem Description
It was reported that 2 grav set 20dp v/nv w/ckv 3ss 104-in experienced component separation.The following information was provided by the initial reporter: event 1: it was reported that the iv tubing set was incomplete and missing the end piece.Event 2: it was reported that the iv tubing set was incomplete and missing the end piece.I was onsite at the user facility - same day surgery - for some piv follow-up.While i was there, a team lead approached me about issues with the carefusion iv tubing that they use for surgery.She had two incidences of faulty iv tubing.Both sets were incomplete, without the end piece attached.She does still have those faulty sets and the packages they came in.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/1/2020.H.6.Investigation: a complaint of a misassembled set was received for investigation.One sample was returned.The customer complaint was verified through visual inspection of the sample.Instead of a male luer at the end of the set an upside y-site was attached.A device history record review for model 42493e lot number 20065512 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this defect is assembly error during the manufacturing process.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of misassembly with lot #20065512 regarding item #42493e.H3 other text : see h.10.

• Brand Name: GRAV SET 20DP V/NV W/CKV 3SS 104-IN
• 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: 10939004
• Report Number: 9616066-2020-20503
• Device Sequence Number: 17217193
• Product Code: FPA
• UDI-Device Identifier: 10885403235375
• UDI-Public: 10885403235375
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 12/15/2020

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 Catalogue Number: 42493E
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1