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 Known Impact Or Consequence To Patient (2692)
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 following were reviewed as part of this investigation: patient severity, trend 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 luer hub was confirmed; however, the cause was undetermined.The product returned for evaluation was one 12fr optidrain pigtail non-locking drainage catheter.Usage residues were observed throughout the sample.Two circumferentially opposite, longitudinally aligned splits were observed in the luer hub, extending from the proximal end past the silicone sleeve.Microscopic inspection of the splits revealed sharply defined granular edges.Inspection of the threads was unremarkable.Inspection of the orifice cross-section did not reveal any damage or deformation.The unremarkable threads suggested that over-tightening of a luer-lock device was not the cause of the observed fracturing.Forceful insertion of a tapered device such as a slip-fit style luer adapter may have contributed to the observed fracturing; however, attempts to replicate the damage using slip-fit devices were unsuccessful, suggesting that an addition factor(s) contributed to the complaint sample damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.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 ward nurse found a crack over the hub of the drainage catheter.The catheter was replaced by an interventional radiologist.No patient injury reported.

• 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: 6364927
• Report Number: 3006260740-2017-00160
• Device Sequence Number: 10775183
• 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
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1