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)
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: all necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot in regards to the described problem.The lot met all release criteria.Investigation summary: one tunneler and one 27cm glidepath were returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as the sample evaluation confirmed a broken tunneler tip and this is a known issue for glidepath tunnelers.The end fragment of the catheter loading tip on the tunneler was broken in two pieces and the break surfaces were smooth and uneven.The definitive root cause could not be determined based upon available information.However, it is likely that supplier related issues contributed to the reported event.
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).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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: 8452078
• Report Number: 3006260740-2019-00674
• Device Sequence Number: 16804249
• 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): 06/21/2019

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; 06/13/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/05/2019; 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1