MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F KIT (19CM) (CURVED); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5704150
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	05/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.Device not returned yet.
Event or Problem Description
It was reported that the package was already open when the nurse went to open it.There was an alleged rip/tear in the package itself.This was discovered before use on the patient.Another device was used to complete the procedure.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: one 14.5 fr d/l hemosplit hemodialysis x 19cm catheter with surecuff was returned for evaluation.A visual evaluation was performed.The investigation is inconclusive for holes, cuts, tears in package, as the device was received with the inner tray was partially opened and was resealed with tape.Residue was noted on the petg on the entire length of the detached area.Although, the kit was opened upon return it is unknown whether the tears could have been from clinical procedure or packaging return procedure.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.
Event or Problem Description
It was reported that the package was already open when the nurse went to open it.There was an alleged rip/tear in the package itself.This was discovered before use on the patient.Another device was used to complete the procedure.There was no reported patient contact.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F KIT (19CM) (CURVED)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7745314
• Report Number: 3006260740-2018-01932
• Device Sequence Number: 1405450
• Product Code: MSD
• UDI-Device Identifier: 00801741012907
• UDI-Public: (01)00801741012907
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: 5704150
• Device Catalogue Number: 5704150
• Device Lot Number: REAY0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 07/15/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 60