MAUDE Adverse Event Report: CAREFUSION, INC PLEURX LOCKABLE DRAINAGE LINE KIT - 50-7265; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Model Number	50-7265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported that caller placed thumb over the sheath and the patient took a deep breath pulling air into the pleural space.Caller states she confirmed with x-ray there is air in the pleural space.Verbatim: caller states she placed a pleurx catheter today.She states she had her thumb over the sheath and the patient took a deep breath pulling air into the pleural space.Caller states she confirmed with x-ray there is air in the pleural space.Caller states she will need to place the patient to wall suction for now.How do we achieve this? do you have an adapter for wall suction? response: informed caller that product code 50-7265 is the pleurx lockable drainage line kit.Emailed ifu for thepleurx lockable drainage line kit.The pleurx lockable drainage line kit (ref 50-7265) is indicated for use only with the pleurx catheter for intermittent drainage.The pleurx lockable drainage line kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).Please review page 12 of the pleurx catalog for more information about the pleurx lockable drainage kit.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.H3 other text : see manufacturer here.
Event or Problem Description
Material no: unknown.Batch no: unknown.  it was reported that caller placed thumb over the sheath and the patient took a deep breath pulling air into the pleural space.Caller states she confirmed with x-ray there is air in the pleural space.Verbatim: caller states she placed a pleurx catheter today.She states she had her thumb over the sheath and the patient took a deep breath pulling air into the pleural space.Caller states she confirmed with x-ray there is air in the pleural space.Caller states she will need to place the patient to wall suction for now.How do we achieve this? do you have an adapter for wall suction? response informed caller that product code 50-7265 is the pleurx lockable drainage line kit.Emailed ifu for thepleurx lockable drainage line kit.The pleurx lockable drainage line kit ((b)(4)) is indicated for use only with the pleurx catheter for intermittent drainage.The pleurx lockable drainage line kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).Please review page 12 of the pleurx catalog for more information about the pleurx lockable drainage kit.
Event or Problem Description
Material no: 50-7265.Batch no: unknown.  it was reported that caller placed thumb over the sheath and the patient took a deep breath pulling air into the pleural space.Caller states she confirmed with x-ray there is air in the pleural space.Verbatim: caller states she placed a pleurx catheter today.She states she had her thumb over the sheath and the patient took a deep breath pulling air into the pleural space.Caller states she confirmed with x-ray there is air in the pleural space.Caller states she will need to place the patient to wall suction for now.How do we achieve this? do you have an adapter for wall suction? response informed caller that product code 50-7265 is the pleurx lockable drainage line kit.Emailed ifu for thepleurx lockable drainage line kit.The pleurx lockable drainage line kit (ref 50-7265) is indicated for use only with the pleurx catheter for intermittent drainage.The pleurx lockable drainage line kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).Please review page 12 of the pleurx catalog for more information about the pleurx lockable drainage kit.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

• Brand Name: PLEURX LOCKABLE DRAINAGE LINE KIT - 50-7265
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 12554402
• Report Number: 9680904-2021-00097
• Device Sequence Number: 4220839
• Product Code: PNG
• UDI-Device Identifier: 10885403185199
• UDI-Public: (01)10885403185199
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K160437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2021

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 Model Number: 50-7265
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/08/2021; 11/03/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/08/2021; 11/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other