MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 12F PIGTAIL; PATIENT CARE SUCTION APPARATUS

Catalog Number	NOD12PT
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of gfyh1272 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (gfyh1272) have been reported from the same (b)(4) facility.
Event or Problem Description
It was reported that the implicated catheter was inserted in the angiography suite on (b)(6) 2017 and the patient was sent back to the ward.The doctor/nurse found the tube leaking the next day and reported a broken hub.The patient was sent to back to the angio suite for tube replacement.The catheter was replaced by interventional radiologist.No patient injury was reported.
Additional Manufacturer Narrative
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.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a cracked connector was confirmed but the exact cause remained unknown.The product returned for evaluation was an optidrain drainage catheter.The catheter had been cut near the connector resulting in two sample segments.Gross visual evaluation of the connector confirmed that the connector was badly damaged with a large segment broken from the main connector and was not returned.The break had occurred in the longitudinal direction and extended beyond the grip tabs.Microscopic examination of the connector damage revealed that the luer threads on the remaining connector had also broken away from the connector.An additional crack was observed which traversed through the grip tab and followed a curvilinear path in an ending point approximately 45° from the starting location.The observed fracture features were characteristic of a brittle material failure.The broken luer threads suggested that extreme force had been experienced at the luer threads and this force may also be related to the overall damage on the luer.Ultimately the exact cause for the brittle break was not determined through evaluation of the physical sample.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.

• Brand Name: NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 12F PIGTAIL
• Common Device Name: PATIENT CARE SUCTION APPARATUS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6370397
• Report Number: 3006260740-2017-00169
• Device Sequence Number: 783195
• Product Code: GBX
• UDI-Device Identifier: 00801741037078
• UDI-Public: (01)00801741037078(17)170930(10)GFYH1272
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: NOD12PT
• Device Lot Number: GFYH1272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1