MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC CLOSED WOUND SUCTION EVACUATOR

Catalog Number 0070740

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the user found the suction port of the device being broken prior to use.The user was not able to connect the drain and the bag.

Event Description

It was reported that the user found the suction port of the device being broken prior to use.The user was not able to connect the drain and the bag.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted one opened (without original packaging), silicone bulb evacuator.Visual inspection of the sample noted that the evacuator tube connector portion (stem) had been broken off and a visibly jagged edge remained on the spout.This is out of spec per inspection procedure which states, "no damaged components are allowed" and "no sharp edges allowed." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, "base¿s o.D.Of cap (inlet/outlet port) not within specification." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿wound drains are used to remove exudates from wound sites.Iii.Contraindications: none known.Iv.Precautions: 1.Ensure that the wound site is dry and free of debris before closure.2.The surgeon must determine the number of drains needed for an effective drainage of the entire wound site.3.The junction between the tubing and tissue at the drain entrance site must be air-tight for effective functioning of the system.4.If the drain is occluded, irrigation and/or aspiration of the drain may be required.5.The quality and quantity of drained fluid must be regularly monitored and reported to the surgeon.6.Reservoir, once full, must be emptied per hospital protocols.Failure to do so will result in incomplete drainage.7.Suction must be discontinued prior to the removal of the drain.8.Before starting the drainage procedure, ensure that all the connections are tight and free of any obstructions within the drainage pathway.Connections to check are: i) drain to suction source.Ii) y-connector (when applicable): ¿ drain to y-connector ¿ y-connector to suction source.9.Di(2-ethylhexyl) phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks.".

• Brand Name: RELIAVAC CLOSED WOUND SUCTION EVACUATOR
• Type of Device: SUCTION EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8813104
• MDR Text Key: 152040288
• Report Number: 1018233-2019-04110
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049569
• UDI-Public: (01)00801741049569
• 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
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 0070740
• Device Lot Number: NGCS1795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1