MAUDE Adverse Event Report: BECTON DICKINSON SAFE-T PLUS THORACENTESIS/PARACENTESIS; INTRAVASCULAR CATHETER

Model Number	TPT1000SP
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the safe-t plus thoracentesis/paracentesis catheter left in the patient was "too flexible/pliable" after removing the needle, requiring an incision to obtain appropriate drainage.The following information was provided by the initial reporter: "according to their report the catheter that is left in the patient after removing the needle is too flexible/pliable.This causes the physician to have to use 2 sometimes 3 kits to gain appropriate access.It was noted especially when using the product for paracentesis they often have to make an incision to obtain appropriate drainage whereas with prior products no incision was required.This increases the risk for bleeding and leakage.The pressure of the adipose layer occludes the catheter due to its extreme flexibility making the product ineffective for its intent.".

• Brand Name: SAFE-T PLUS THORACENTESIS/PARACENTESIS
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10253603
• Report Number: 2243072-2020-01035
• Device Sequence Number: 13714664
• Product Code: FOZ
• UDI-Device Identifier: 10885403108433
• UDI-Public: 10885403108433
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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: Other
• Device Model Number: TPT1000SP
• Device Catalogue Number: TPT1000SP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/09/2020
• 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: Other