MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 10F PIGTAIL; PATIENT CARE SUCTION APPARATUS

Catalog Number	NOD10PT
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Death (1802); Pneumothorax (2012)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 a pigtail drain was placed in a patient with respiratory insufficiency and pronounced pleural effusion without complications.The next day, a cxr revealed an ipsilateral apical pneumothorax.A defective cone on the pigtail was discovered and the device was removed and 2.5 liters of serous pleural fluid was emptied.It was further reported that the patient died 2-3 days after the placement procedure, but allegedly not in connection with the complaint but due to malignant pleural effusion.
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample returned was 2 navarre drainage catheters with pigtail feature and one 2 way luer valve of unknown manufacturer.The unsealed navarre catheter luer was observed to be cracked, therefore the investigation is confirmed for (b)(4) - connector break/crack and unconfirmed for (b)(4) -damaged/defective connector.The sealed navarre catheter did not display damage or issue, therefore it is unconfirmed for (b)(4) - connector break/crack.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that a pigtail drain was placed in a patient with respiratory insufficiency and pronounced pleural effusion without complications.The next day, a cxr revealed an ipsilateral apical pneumothorax.A defective cone on the pigtail was discovered and the device was removed and 2.5 liters of serous pleural fluid was emptied.It was further reported that the patient died 2-3 days after the placement procedure, but allegedly not in connection with the complaint but due to malignant pleural effusion.

• Brand Name: NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 10F 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: 7677651
• Report Number: 3006260740-2018-01670
• Device Sequence Number: 11131454
• Product Code: FGE
• UDI-Device Identifier: 00801741037047
• UDI-Public: (01)00801741037047
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NOD10PT
• Device Lot Number: GFBV3901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention