MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SL CV FOR MARQUET PSI; CATHETER SECUREMENT DEVICE

Catalog Number 0684000472

Device Problem Mechanics Altered (2984)

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.The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of rezb1073 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (juzff035) have been reported from one facility.

Event Description

Distributor reported finding an alleged open seal on a statlock during product inspection.

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 an open seal was confirmed and the cause appears to be manufacturing related.The product returned for evaluation was one statlock stabilization device for maquet intra-aortic balloon (iab) catheter package.The package was returned with the statlock device within.Gross examination of the package revealed that the top seal and side seals were complete and contained no voids or gaps in the adhesive transfer and bonding between the tyvek lidstock and clear plastic back cover.However, the seal at the bottom of the package contained a void in the adhesive transfer and bonding between the tyvek lidstock and clear plastic back cover.It appears the manufacture seal of this package was never complete.The root cause for this event has been identified and corrective action(s) have been determined.

• Brand Name: SL CV FOR MARQUET PSI
• Type of Device: CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 5148608
• MDR Text Key: 28625345
• Report Number: 3006260740-2015-00473
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 5
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0684000472
• Device Lot Number: JUZFF035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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