MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LINE DRAW ARTERIAL BLOOD SAMPLING KITS; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS

Model Number	4041LH
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: no product sample was received; therefore, visual and functional testing could not be performed.The reported problem could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.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.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the slip tip syringe does not work with the peripheral iv tubing.This caused bubble to develop in the syringe.No patient injury was reported.

• Brand Name: LINE DRAW ARTERIAL BLOOD SAMPLING KITS
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15353753
• Report Number: 3012307300-2022-17602
• Device Sequence Number: 6049780
• Product Code: JKA
• UDI-Device Identifier: 20351688061420
• UDI-Public: 20351688061420
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2022

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: 4041LH
• Device Catalogue Number: 4041LH
• 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: 05/24/2022
• Initial Report FDA Received Date: 09/04/2022
• 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