MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD INLAY URETERAL STENT

Catalog Number 778626

Device Problems Break (1069); Out-Of-Box Failure (2311)

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

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.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.

Event Description

It was reported that the product is broken when the package was opened.

Manufacturer Narrative

Received 1 used inlay ureteral stent with the original unit packaging.During the visual evaluation it was observed that the kidney end of the stent was broken.The broken section presented with stress marks as if the stent had been stressed beyond its tensile capabilities.The stent was received out of its individually sealed polybag.The following functional evaluation was performed: take a guidewire of 0.038 in as recommended per instructions for use.Submerged the guidewire and stent in water to activate their coating.Slipped the guidewire through the stent.During the evaluation the stent passed through the guidewire with out any difficulties.A dimensional evaluation was performed: stent length = 10.125 in (specification is 10.24 in ± 0.200 in).Outer diameter = 0.079 in (specification is 0.079 in ± 0.002 in).Inner diameter = 0.050 in (specification is 0.049 in ± 0.002 in).The stent dimensions was found to be within specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The reported issue was confirmed with an unknown root cause.The instructions for use state the following: " improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.Exercise care.Tearing of the stent can be caused by sharp instruments.Care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." (b)(4).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.

• Brand Name: BARD INLAY URETERAL STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5250167
• MDR Text Key: 32263729
• Report Number: 1018233-2015-00502
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

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: 12/29/2019
• Device Catalogue Number: 778626
• Device Lot Number: NGZD4477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• 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