MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number M120081

Device Problems Moisture Damage (1405); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Operating room received some pg kits and there allegedly was water damage on one of the boxes.It reportedly leaked through and contaminated the packaging and some of the draping on some of the kids.There were 5 kits total that were reported affected.

Event Description

Operating room allegedly received some power glide kits on (b)(6) and there was water damage on one of the boxes.It allegedly leaked through and contaminated the packaging and allegedly some of the draping on some of the kits.There were 5 kits total that were reportedly affected.

Manufacturer Narrative

The device has not been returned to the mfr, at this time for eval.A lot history review (lhr) of rezc2456 showed no other similar product complaint(s) from these lot numbers.

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 complaint of staining on the packages was confirmed but the cause was unknown.The returned products were five sealed 20g powerglide kits.All seals were intact, and the exterior packaging did not contain any damage.However, all five kits contained brown stains that appeared to have originated from a liquid.The stains soaked through the tyvek packaging and into the blue drape inside the package.No remaining dampness was found on the samples.No other damage or abnormalities were found with the returned kits.Manufacturing procedures and inspection requirements for the package boxing and individual item package require 100% inspection of each item for this type of damage at the manufacturing facility.It is likely that the damage occurred following the shipment of the item from the distribution center (and as a result, outside of manufacture control).

Manufacturer Narrative

Due to a technical issue, the data in the following fields were not transmitted electronically in the previous submission.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: POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (8CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas UT ; MX
• 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: 4859229
• MDR Text Key: 5848506
• Report Number: 3006260740-2015-00280
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M120081
• Device Lot Number: REZC2456
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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
• Patient Outcome(s): Required Intervention