MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PENROSE DRAIN 12" (304.8MM), X-RAY OPAQUE LATEX RUBBER, 1/4" (6.35MM), STERILE

Catalog Number	0912010
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the tip of one end of the penrose drain appeared to be dirty.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection noted a black smear of material on the end of the device through the clear unopened package.There was scotch tape on two ends, but it was found that the original seal of the unit was in tact.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿description: gravity drains are drains used to promote drainage in open surgical wounds.Indications for use: bard® gravity drains are indicated for use for open wound drainage.Contraindications: contraindicated for patients with known allergies to natural rubber latex.Warnings: to avoid the possibility of drain damage or breakage: avoid suturing through drains as this may result in breakage during removal or undesired leakage.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 which could cause cuts or nicks and lead to subsequent structural failure of the drain; and surgical removal may be necessary if drain is difficult to remove or breaks.Drain placement the surgeon should irrigate the wound with sterile fluid, then suction the irrigating fluid and gross debris from the operative site.Tubes should lie flat and in line with the anticipated skin exit.To facilitate later removal by manual traction, the tubing should not be curled, pinched, or sutured internally.Positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the operating surgeon.Drain tubing should be placed within areas of critical fluid collection.Care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.Taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain displacement.Care must be exercised to avoid damage to the drain (see warnings).The tubing should be repeatedly checked during closure for free motion to avoid fluid retention, breakage and/or fragment retention within the wound.Latex caution: this product contains natural rubber latex which may cause allergic reactions.Do not use lubricants containing mineral oil or petrolatum as they are harmful to rubber.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Consult instructions for use.Caution, consult accompanying documents.Use by.Do not resterilize.Do not use if package is damaged.Lot number.Units.Catalog number.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Sterilized using ethylene oxide.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.Ec rep keep away from sunlight.Manufacturer.Authorized representative.X-ray opaque rubber".
Event or Problem Description
It was reported that the tip of one end of the penrose drain appeared to be dirty.

• Brand Name: PENROSE DRAIN 12" (304.8MM), X-RAY OPAQUE LATEX RUBBER, 1/4" (6.35MM), STERILE
• Common Device Name: PENROSE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7479614
• Report Number: 1018233-2018-01404
• Device Sequence Number: 159644
• Product Code: GBX
• UDI-Device Identifier: 00801741051234
• UDI-Public: (01)00801741051234
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 0912010
• Device Lot Number: NGBX0393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1