MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO FT CATHETER W/SHERLOCK TPS STYLET 5F MAXIMAL BARRIER TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reft1120 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "i was assist my new member to insert a picc last friday, she accessed a vein with 21 g needle to brachial vein, vein was collapsed even was right place, she took out the needle right away and noticed needle was split".Additional info.Received 10/06/2021 "patient or insertor were not injured from broken 21g needle.Insertor was successful picc insertion with 2nd attempt , used extra needle 1 3/4" 20g from 1st opened picc tray".
Event or Problem Description
It was reported "i was assist my new member to insert a picc last friday , she accessed a vein with 21 g needle to brachial vein , vein was collapsed even was right place, she took out the needle right away and noticed needle was split" additional info.Received 10/06/2021 "patient or insertor were not injured from broken 21g needle.Insertor was successful picc insertion with 2nd attempt , used extra needle 1 3/4" 20g from 1st opened picc tray".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged introducer needle is confirmed but the exact cause remains unknown.Two photo samples of an introducer needle were provided for evaluation.The first image shows the needle on a drape.The luer hub and safety mechanism are shown to be detached from the needle shaft.Blood residue is present on the device.No apparent deformation is visible on the needle shaft.The hub or safety mechanism could not be clearly inspected for the presence of material damage or cracks.Based on the information provided, possible contributing factors include damaged components and use conditions.Since the hub and safety mechanism were observed to be detached from the needle, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC SOLO FT CATHETER W/SHERLOCK TPS STYLET 5F MAXIMAL BARRIER TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12705047
• Report Number: 3006260740-2021-04574
• Device Sequence Number: 4103691
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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 Model Number: N/A
• Device Catalogue Number: 1295108FD
• Device Lot Number: REFT1120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown