MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO PROTECTIV SAFETY I.V. CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	308700
Medical Device Problem Codes	Component Missing (2306); Device Markings/Labelling Problem (2911); Missing Information (4053)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to manufacturer, but a photograph was provided for evaluation.The photo displayed evidence of a missing label print and empty blister packages, confirming the reported issues.Any in-process product is inspected by trained operators using statistically valid sampling plans at defined intervals.If any nonconformance's are found in process, the product is isolated, non-conformed and immediate corrective action is taken.As a correction to this issue, the returned photo was forwarded to the appropriate personnel notifying of the reported complaint.This event is considered to be an isolated event and not the result of a systemic quality related issue due to no other similar reported complaints for the reported device lot.No additional corrections or corrective actions conducted by the manufacturing facility at this time.
Event or Problem Description
Information was received that a smiths medical jelco protective safety i.V.Catheter was missing from the peel pack and also had a missing label print on the packaging.No adverse patient effects were reported.

• Brand Name: JELCO PROTECTIV SAFETY I.V. CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8043978
• Report Number: 3012307300-2018-08068
• Device Sequence Number: 19213662
• Product Code: FOZ
• UDI-Device Identifier: 10351688071323
• UDI-Public: 10351688071323
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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: No Information
• Device Expiration Date: 07/17/2021
• Device Catalogue Number: 308700
• Device Lot Number: 3658565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1