MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAFETY PROTECTIV CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number	305506
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device shear when withdrawing the intravenous (iv).
Additional Manufacturer Narrative
This mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.Complainant returned two photos for analysis.The first photo displayed the blister package top stock confirming the affected product lot.The second photo displayed a used catheter assembly with evidence of catheter shear and damage to catheter bevel tip.Unfortunately, the photos taken of the complaint sample does not include magnified closed up views of the catheter bevel tip for evidence of mechanical witness marks or manufacturing damage or of needle guard assembly for cannula bevel tip irregularities, excess adhesive, or manufacturing damage.Given the actual sample was not returned, we were unable to perform an in-depth investigation.Causal factor could not 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 was released after the review of all acceptance of applicable documentation.Premature removal of the introducer needle from the catheter can result in catheter shear upon insertion.The catheter was thin wall by design and needs the needle in order to thread properly into the vessel, with the needle acting as a guide wire during the process.Additionally, in terms of background information, it was important to note that catheter shear can be attributed to practices not supported by the infusion nurses society standards of practice.These types of practices include, but were not limited to, reinsertion of the needle during initial intravenous (iv) placement.In-process, product was evaluated for fta (force to advance) and ftl (force to lock) and visually inspected by operators using statistically valid sampling plans at defined intervals.If any nonconformances are found in process, the product was isolated, non-conformed and immediate action was taken to perform corrections.Inspections and tests were conducted by trained operators using statistically valid sampling plans at defined intervals.Sampling plans were based on random sampling selection and were designed to provide a high level of assurance that the true fraction defective was less than or equal to the established acceptable quality level (aql) level for each quality characteristic.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.As reported, the reported event could not be verified and/or confirmed with confidence, therefore, no further correction, corrective or preventive actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Manufacturing regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.

• Brand Name: JELCO SAFETY PROTECTIV CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• 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: 16885306
• Report Number: 3012307300-2023-05284
• Device Sequence Number: 6091938
• Product Code: FOZ
• UDI-Device Identifier: 10351688071095
• UDI-Public: 10351688071095
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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 Model Number: 305506
• Device Catalogue Number: 305506
• Device Lot Number: 4188158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown