MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PENROSE DRAIN 18" (457.20MM), X-RAY OPAQUE LATEX RUBBER, 3/8" (9.53MM), STERILE

Catalog Number 0918020

Device Problems Break (1069); Material Puncture/Hole (1504)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

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 multiple holes were found within the penrose drain.

Manufacturer Narrative

The reported event was confirmed.The sample was received opened and with the original packaging.Visual evaluation noted two large tears, the tears did not line up when the device and were in the folded configuration for the packaging.The blister packaging showed no signs of mishandling or wear.The tears were longitudinal on the device and measured 0.452in and 0.108.The distance between the tears was 4.8in.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: ¿bard intermittent catheters (latex) instructions for use indications for use: for urological use only.Single-use.Single patient use, do not reuse.Do not use if package is opened or damaged.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: this product contains natural rubber latex which may cause allergic reactions.Warnings: ¿ on latex and red rubber catheters, do not use ointments or lubricants having a petrolatum base.They will damage latex.¿ visually inspect the product for any imperfections or surface deterioration prior to use.¿ 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 failure, and/or to injury, illness or death of the patient.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Adverse reactions urinary tract infection bleeding from the urethra irritation of the urethra instructions for intermittent catheters: 1.Wash your hands thoroughly with soap and water.2.Remove catheter from the pack.3.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.4.Gently insert rounded end of catheter into urethra.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands.Caution: federal (u.S.A.) laws restricts this device to sale by or on the order of a physician.".

Event Description

It was reported that multiple holes were found within the penrose drain.

• Brand Name: PENROSE DRAIN 18" (457.20MM), X-RAY OPAQUE LATEX RUBBER, 3/8" (9.53MM), STERILE
• Type of Device: PENROSE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8095200
• MDR Text Key: 128072494
• Report Number: 1018233-2018-05573
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741051319
• UDI-Public: (01)00801741051319
• 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
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 0918020
• Device Lot Number: NGCN3940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1