MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD DAVOL RELIAVAC PVC DRAIN CONNECTOR TUBING; DAVOL RELIA VAC

Catalog Number 0034810

Device Problem Complete Blockage (1094)

Patient Problems Swelling (2091); Thrombus (2101)

Event Date 12/01/2015

Event Type  Injury  

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.The device was not returned.

Event Description

It was originally reported that six days after the start of use, the drain tube clogged due to thrombus.It was later reported that on (b)(6), clogging of the drain tube was observed, the clog was reported as thrombus, and the patient allegedly became swollen.The drain tube was removed from the patient.The patient recovered well and no additional treatment was given.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "indications: silicone round drains are indicated for use with selected bard® evacuators for closed wound drainage following head and neck, abdominal, ent, ob/gyn, plastic and neurosurgery.Warning: when placing drain(s) care should be taken to ensure that the perforated portion of the wound drain lies completely within the confines of the wound.Read product insert provided with the closed wound evacuator for detailed instructions, warnings and precautions associated with the use of the evacuator device.To avoid the possibility of drain damage or breakage: ¿ additional perforations should not be made in the drains.¿ avoid suturing through drains.¿ drains should lie flat and in line with the skin exit areas.¿ particular care should be taken to avoid any obstacles to the drain exit path.¿ drains should be checked for free motion during closure to minimize the 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.Drain placement 1.- place performed wound drain within the critical fluid collection area of wound.2.- draw non-perforated section of wound drainage through to the outside until drain indicator mark appears at skin surface.Two set of indicator marks aid placement of the drain.3.- remover trocar only by cutting the drain one inch from end of the trocar.4.- trim non-perforated section of drain to desired length." (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.The device was not returned.

Event Description

It was originally reported that six days after the start of use, the drain tube clogged due to thrombus.It was later reported that on (b)(6), clogging of the drain tube was observed, the clog was reported as thrombus, and the patient allegedly became swollen.The drain tube was removed from the patient.The patient recovered well and no additional treatment was given.

• Brand Name: BARD DAVOL RELIAVAC PVC DRAIN CONNECTOR TUBING
• Type of Device: DAVOL 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: 6375039
• MDR Text Key: 68968941
• Report Number: 1018233-2017-00849
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0034810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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