MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STRAIGHT, POLYURETHANE CATHETER, EXCHANGE KIT WITH AIRGUARD VALVED INTRODUCER; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	5397230
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the device was provided.The device history records are currently under review.The return of the sample is pending.The investigation is currently underway.
Event or Problem Description
It was reported that during preparation for chronic catheter placement, the white plastic tunneler tip allegedly was cracked and the tip broke off.Another device was used to complete placement.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot met all release criteria.Dhr was reviewed and no deviations/issues were identified or associated with this problem in regards to product materials or during manufacturing, packaging or qc inspection process.Investigation summary: one tunneler and one 27cm glidepath was received for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as the proximal tip of the tunneler was broken off and the surfaces of the broken tunneler tip match up.The exact root cause for the damaged tunneler could not be determined.However, it is likely that supplier issues may have contributed to reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(expiry date: 03/2020).
Event or Problem Description
It was reported that during preparation for chronic catheter placement, the white plastic tunneler tip allegedly was cracked and the tip broke off.Another device was used to complete placement.There was no reported patient contact.
Additional Manufacturer Narrative
The lot number of the device was provided.The device history records are currently under review.The sample was returned for evaluation.The investigation is currently underway.(expiry date: 03/2020).
Event or Problem Description
It was reported that during preparation for chronic catheter placement, the white plastic tunneler tip allegedly was cracked and the tip broke off.Another device was used to complete placement.There was no reported patient contact.

• Brand Name: STRAIGHT, POLYURETHANE CATHETER, EXCHANGE KIT WITH AIRGUARD VALVED INTRODUCER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8450142
• Report Number: 3006260740-2019-00671
• Device Sequence Number: 14257714
• Product Code: MSD
• UDI-Device Identifier: 00801741012303
• UDI-Public: (01)00801741012303
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2019

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: 5397230
• Device Catalogue Number: 5397270
• Device Lot Number: RECX1119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 03/11/2019; 05/23/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/09/2019; 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1