MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® RECTAL TUBE

Model Number	0006510
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 teal connector piece of the rectal tube had pieces coming off into the tube.The complainant stated that thermo fisher scientific "re-assembles" the device by adding a "reducer component" and an additional tube.It was reportedly noticed after the re-assembly.
Event or Problem Description
It was reported that the teal connector piece of the rectal tube had pieces coming off into the tube.The complainant stated that thermo fisher scientific "re-assembles" the device by adding a "reducer component" and an additional tube.It was reportedly noticed after the re-assembly.
Additional Manufacturer Narrative
Received 8 unopened and 1 opened rectal tubes for evaluation.The reported issue was confirmed.During visual evaluation, it was noted that the nine samples had assembled an additional tube with a reducer component not apart of the structure of product #0006510.The samples 1,2,3,4,7 had a green colored loose material inside of the tube.The green colored loose material was evaluated and found to be of the same material with which the connector of the rectal tube is manufactured.This issue was caused during the process of assembly of the tube with a reducer component to the connector of the rectal tube.This assembly was made by bard nogales.During the visual evaluation of the samples 5,6, 8 and 9 this issue was not observed.Reviewed the manufacturing process and did not find any potential root cause that could have contributed to the alleged failure.According to the description of the reported event " the complainant stated that thermo fisher scientific "re-assembles" the device by adding a "reducer component" and an additional tube.It was reported that the reported event was noticed after the re-assembly ".By condition of the samples determined to be the result of post-manufacturing damage and outside the control of manufacturing.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "used in the administration of enemas and certain medications.Radiopaque for use in barium and other contrast media enema administration.Features open distal tip and one side eye.Warnings: ¿ do not use in patients who had colorectal surgery within the last year.¿ do not use in patients with known rectal or anal injury or in patients with known stenosis that could be reached with the device inserted.¿ not for use in patients with suspected or confirmed rectal mucosa impairment.E.G., severe proctitis, ischemic proctitis, mucosal ulcerations or patients with known severe external and internal hemorrhoids.¿ do not advance against resistance.¿ not for use on patients with indwelling rectal or anal devices (e.G.Thermometer) or delivery mechanism (e.G.Suppositories) or enemas in place.¿ do not use on patients known to be sensitive to or allergic to any components within the system.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.Instructions for rectal tube 1.Place pad under patient buttocks.2.Position the patient on left side.3.Don gloves.4.Lubricate the patient¿s anus, preferably with a viscous lubricant.5.Lubricate the distal 2 inches of the rectal tube tip with supplied lubricant.6.Gently insert the rectal tube tip into the rectum and advance 2-4 inches.Never advance forcefully if resistance is encountered.7.Encourage patient to breathe slowly and deeply during insertion.8.Ensure rectal tube is correctly position intraluminally (follow institutional guidelines or doctors¿ orders).9.Slowly instill the solution.10.Withdraw rectal tubing after solution has been instilled.11.Instruct patient to hold solution as long as possible.".

• Brand Name: BARD® RECTAL TUBE
• Common Device Name: RECTAL TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7373428
• Report Number: 1018233-2018-00959
• Device Sequence Number: 16722516
• Product Code: KNT
• UDI-Device Identifier: 00801741045974
• UDI-Public: (01)00801741045974
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: Other
• Device Model Number: 0006510
• Device Catalogue Number: 0006510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1