MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM); BLOOD ACCESS AND ACCESSORIES

Catalog Number 5833690

Device Problems Device Damaged Prior to Use (2284); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: after reviewing the complaint and the returned photograph, the complaint was confirmed, and it appears that the product was damaged outside bard¿s control.Exactly how or when the package was damaged cannot be verified.The returned photograph showed the bottom right corner of a hemostar catheter tray.The complete tray was not visible in the photograph.The bard end label was observed on the bottom edge of the white tyvek sheet.The part number listed on the label was 5833690.The chinese label was applied further up on the tyvek sheet, which indicates that the damage occurred between the application of the chinese label and unpacking the tray at the user facility.What appeared to be a ¿v¿-shaped tear was observed along the right edge of the tyvek sheet.The tyvek flap made by the ¿v¿-shaped tear was wrinkled, which indicates a point contact tear that initiated at the tip of the ¿v¿ and pushed the tyvek toward the bottom of the tray.After reviewing the photograph, the packaging engineer commented that the damage may have been caused by either something dragging across the packaging or the kit caught on something sharp.The source of the damage seems to have come from an external source.There are no sharp tray edges inside the packaging at the location of the tear.The 5-pack shipper box contains nothing that would damage the tray in this manner.The damage observed on the returned kit appears to have occurred outside bard¿s control and may have occurred while in transit, storage, or unpacking.A review of the manufacturing records (e.G.Device history and material reject records) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot.A lot history review (lhr) of reau0064 showed no other similar product complaint(s) from this lot number.

Event Description

Nurse reported that the product was damaged upon receipt.On (b)(6) 2016 - the reported damage was to the kit package, not the shipping box.The provided photo shows a tear in the tyvek.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM)
• Type of Device: BLOOD ACCESS AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 6247688
• MDR Text Key: 65091322
• Report Number: 3006260740-2016-00723
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386(17)180528(10)REAU0064
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/23/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Catalogue Number: 5833690
• Device Lot Number: REAU0064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1