MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; PERIPHERAL INTRAVENOUS CATHETERS

Model Number	306301
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the product tears the patients skin upon entry.Making venipuncture difficult and requiring several attempts.There was no report of patient harm.
Additional Manufacturer Narrative
No complaint sample was returned to manufacturing for evaluation.Given that no product has been received.And the investigation could not confirm, whether a quality related issue has resulted in the customer reported problem, no causal factor could be defined with confidence.All materials in the manufacturing process, as well as all finished good products, are released to market based on approved quality specification.Product is released after the review of all acceptance of applicable documentation.Root cause of the reported issue cannot be determined, as no sample was received for evaluation.No corrective action will be taken at this time.If a sample is subsequently received, the manufacturer will reopen this file at that time.As necessary in accordance with 21 cfr 803.56, when additional reportable information becomes available, a supplemental mdr will be filed at that time.Device history record (dhr) review of the provided lot number found no discrepancies or abnormalities relevant to the complaint.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms(b)(4).
Additional Manufacturer Narrative
Correction: b1, corrected data: correction: b1 product problem.

• Brand Name: JELCO
• Common Device Name: PERIPHERAL INTRAVENOUS CATHETERS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17176293
• Report Number: 3012307300-2023-06508
• Device Sequence Number: 6461861
• Product Code: FOZ
• UDI-Device Identifier: 10351688071224
• UDI-Public: 10351688071224
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: Health Professional
• Device Expiration Date: 03/24/2023
• Device Model Number: 306301
• Device Catalogue Number: 306301
• Device Lot Number: 3958629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown