MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (35CM); BLOOD ACCESS AND ACCESSORIES

Catalog Number 5833350

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.The device has not been returned to the manufacturer, at this time, for evaluation.Device not returned.

Event Description

Per voicemail from sales representative, facility reported that they found a "pencil-tip-like" pull in the packaging allegedly breaking the sterility.Facility reportedly did not use the product.Left voicemail with sales representative for additional information.

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: the complaint of a hole in the package was confirmed, but the cause is unknown.One unopened hemostar kit as returned for evaluation.The seal around the entire kit is complete and no gaps are visible in the seal area.The breach is a 1mm x 1mm v-shaped hole, which is located 7.4cm from the left side of the tyvek side of the pouch and 18.0cm from the bottom side of the tyvek.The material between the open or upper end of the v-shaped hole was crumpled, which indicates that something caught the tyvek and pushed the material aside, creating a hole.The tyvek material points inward at the hole, indicating the hole was created from the outside.Two parallel 7cm long impressions that were 7mm apart were found on the external surface of the tyvek side of the pouch 6cm from the hole.The packaging engineering manager indicates that something caught the tyvek and pushed the tyvek aside causing the hole.The source or cause of the hole is unknown.It is possible that the damage occurred during storage or handling at the complainant facility or from shipping.The cause of the complaint could not be verified based on the evidence found on the package.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (35CM)
• 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: christy chandonia ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225631
• MDR Report Key: 5224480
• MDR Text Key: 31462451
• Report Number: 3006260740-2015-00534
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

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: 04/28/2017
• Device Catalogue Number: 5833350
• Device Lot Number: REZF0540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention