MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 PVC DRAIN WITH TROCAR; WOUND DRAIN

Catalog Number 0080710

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.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: "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.To avoid the possibility of drain damage or breakage, please follow these steps: 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.Drains should not be handled with pointed, toothed or sharp instruments as these 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 would drains were not working right.The holes in the drain were allegedly smaller than normal, not located in the normal place, and the drain was not draining.There was no impact to the patient reported.

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 would drains were not working properly.The holes in the drain were allegedly smaller than normal, not located in the normal place, and the drain was not draining.No impact to the patient was reported.

Manufacturer Narrative

Received 3 unopened pvc drains with the trocar and the box labeling.The reported event was unconfirmed, as the problem could not be reproduced.Visual inspection noted no obvious defects.In order to verify the function of drain; the samples were tested as follow: connect the drain to a y-connector and a wound drain evacuator (in house) inflated balloon of evacuator (in house).Close evacuator (in house).Submerged the drain under water.Suction results: sample 1 = 400cc (specification is = 400cc) sample 2 = 400cc (specification is = 400cc) sample 3 = 400cc (specification is = 400cc) during the functional test observed that drain suctioned 400cc.The samples were found to be within specifications.The sample dimensions are as follows: drain eyelets: sample 1 = 0.0498 in (specification is 0.050 in ± 0.006 in) sample 2 = 0.0502 in (specification is 0.050 in ± 0.006 in) sample 2 = 0.0465 in (specification is 0.050 in ± 0.006 in) the samples were found within specifications.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: "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.To avoid the possibility of drain damage or breakage, please follow these steps: 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.Drains should not be handled with pointed, toothed or sharp instruments as these 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 would drains were not working properly.The holes in the drain were allegedly smaller than normal, not located in the normal place, and would not drain.No impact to the patient was reported.

• Brand Name: PVC DRAIN WITH TROCAR
• Type of Device: WOUND DRAIN
• 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: 6118340
• MDR Text Key: 60887541
• Report Number: 1018233-2016-01690
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2016

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: 02/28/2021
• Device Catalogue Number: 0080710
• Device Lot Number: NGAP2848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/27/2016; 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• 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