MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 RELIAVAC CLOSED WOUND SUCTION SYSTEM; RELIA VAC

Catalog Number 0070360

Device Problems Device Damaged Prior to Use (2284); Scratched Material (3020)

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

Event Date 02/27/2017

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 tip of the drain tube was damaged prior to use.After opening the package, the user found that the end of the white drain tube (the side of patient) was jagged.The delay of procedure was limited and no patient injury, such as infection, was reported.In (b)(4) observation, it was confirmed that there was ledge to the end of the white drain tube.Therefore, it seems that this device was deformed and not broken.

Manufacturer Narrative

Received 1 opened wound drain only.Per the visual inspection, it was noted that the white part had a flash.The reported event was confirmed as manufacturing related.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "¿ drains should be checked during closure for free motion to avoid possibility of breakage.Drain removal should be done gently by hand.They should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Surgical removal may be necessary if drain is difficult to remove or breaks." (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.

Event Description

It was reported that the tip of the drain tube was damaged prior to use.After opening the package, the user found that the end of the white drain tube (the side of patient) was jagged.The delay of procedure was limited and no patient injury, such as infection, was reported.In medicon's observation, it was confirmed that there was ledge to the end of the white drain tube.Therefore, it seems that this device was deformed and not broken.

• Brand Name: RELIAVAC CLOSED WOUND SUCTION SYSTEM
• Type of Device: RELIA VAC
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6429855
• MDR Text Key: 70995345
• Report Number: 1018233-2017-01310
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 0070360
• Device Lot Number: NGAU2182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• 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