MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD CATH 'N SLEEVE SUCTION KIT WITH SOLUTION CONTAINER; TRACHEAL CATH 'N SLEEVE

Catalog Number	0089340
Health Effect - Clinical Code	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 upon opening the package, the product within the package was a pediatric catheter rather than the 14fr tracheal suction cath 'n sleeve kit.Allegedly, the product catalog number on the box and on the packaging of the product were the same.
Additional Manufacturer Narrative
Received 30 unopened cath' n sleeve suction kits.The reported event was confirmed as manufacturing-related.During the visual inspection the 30 samples were opened and noted that the catheter configuration did not match the current configuration of catalog 0089340, since the catheter included printing numbers, the 14fr catheter requires a plastic sleeve and no printing is required over the catheter.In order to verify the french of the samples received, they were measured with a french gauge.All 30 samples measured 8 fr.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: "single use.Do not resterilize.Do not use if package is damaged.Not made with natural rubber latex.Sterilized using ethylene oxide" (b)(4).
Event or Problem Description
It was reported that upon opening the package, the product within the package was a pediatric catheter rather than the 14fr tracheal suction cath 'n sleeve kit.Allegedly, the product catalog number on the box and on the packaging of the product were the same.

• Brand Name: BARD CATH 'N SLEEVE SUCTION KIT WITH SOLUTION CONTAINER
• Common Device Name: TRACHEAL CATH 'N SLEEVE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6967622
• Report Number: 1018233-2017-05379
• Device Sequence Number: 1117787
• Product Code: BSY
• UDI-Device Identifier: 00801741050251
• UDI-Public: (01)00801741050251
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2017

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: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 0089340
• Device Lot Number: NGBQ3811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 10/21/2017
• Supplement Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1