MAUDE Adverse Event Report: ARGON MANUFACTURING INC. MEDLINE INDUSTRIES, INC.; DBD-CATH PACK

Model Number	DYNJVB1259A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported; the guidewire provided in medline cath pack (dynjvb1259a) "is losing its coating and fraying with as little as two passes down a catheter and into a patient." email received by (b)(6) bsn, cardiovascular lab lead team member, department of veterans affairs whom provided additional information in regards to this incident.Reporter states, the incident was noted during the procedure, "the wire is wiped down by the scrub with a heparinized saline soaked gauze after it is removed from the body, so most of the flakes likely came off then." reporter states, once the flaking was noticed, "the wire was set aside and the lead team member notified.We switched to a different brand of wire and monitored the patient while we finished the procedure." reporter states, the patient was asymptomatic throughout the procedure and currently reports no symptoms.See sample evaluation report below.Due to the reported incident, medical intervention and in an abundance of caution, a med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.This root cause evaluation is from main complaint ( (b)(4) ), there were four additional complaints ( (b)(4) ) all opened with the same reported issue/concern.(b)(6) 2021 09:29:55 cst ( (b)(4)) sample evaluation: a photo and a sample were received for our investigation.We received one used guidewire as a sample for our investigation.We did not receive the guidewire in the white plastic casing.The rest of the pack was also not received.We observed a large section of the guidewire has lost its green coating and multiple small areas along the wire where the coating rubbed and frayed off.There is no damage to the guidewire and no other notable defect.Finished good pack build reviewed: there were no issues with the pack build that might have an impact on the issue.Trending: trending was reviewed and there have been 4 additional reported complaint(s) for this issue in the past 6 months.Component trending was reviewed and there have been four additional reported complaint(s) for this issue for component (b)(4) the last 6 months.Investigation summary: the account reported finding guidewire losing coating & fraying.The reported issue occurred in item dynjvb1259a (lot 21gla998).Based on the complaint details the root cause is considered to be a vendor product issue relating to the component manufacturing process.Zcd00003/defect confirmed: supplier mfg/error (non-medline branded).Actions taken and recommendations: we will be discontinuing the use of this argon guidewire in all packs immediately due to this being a recurring issue with this vendor's ptfe coated guidewires as well as to prevent this issue from reoccurring and possibly harming patients.We recommend working with the account manager to find an alternative guidewire as this specific component has had this issue in the past and we will be discontinuing this component in all packs moving forward and we recommend not using any of these components that you have on hand.This complaint has been provided to the vendor for further evaluation.Our supplier quality team will also monitor this issue for trending purposes.
Event or Problem Description
It was reported, the guidewire provided in medline cath pack (dynjvb1259a) is losing its coating and fraying with as little as two passes down a catheter and into a patient.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: DBD-CATH PACK
• Manufacturer (Section D): ARGON MANUFACTURING INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 12655852
• Report Number: 1423395-2021-00049
• Device Sequence Number: 17683810
• Product Code: OES
• UDI-Device Identifier: 10193489450873
• UDI-Public: 10193489450873
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: DYNJVB1259A
• Device Catalogue Number: DYNJVB1259A
• Device Lot Number: 21GLA998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 135