MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PG PRO 18G 10CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refr1287 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "during powerglide placement catheter deployed fine but resistance was felt while pulling back to activate safety.Upon removal of needle it was observed that the wire appeared to be short and had sheared off.After further inspection of the device (removing housing to pull wire out and compare wire lengths), it became clear that the safety did not properly deploy and was sitting in front of the needle giving the appearance of a shortened wire.".
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 safety mechanism was confirmed, but the cause of the reported event could not be determined from the photographs that were provided for investigation.The physical sample was not returned for investigation.The photographs showed two disassembled powerglide deployment systems.The handles had been disassembled.The needle had been removed from each handle and the safety mechanism was positioned over each needle tip.One photo showed the guidewire attached to each handle and the guidewire lengths appeared to be the same.Other photos showed the safety mechanism positioned side by side and the safety mechanisms were positioned at a different locations of the needle tip.No portion of the needle tip was exposed outside of the safety mechanism.Only one needle tip was positioned within the protruding tip of the safety mechanism.Based on the position of the safety mechanism in relation to one of the needle tips, the complaint was confirmed, but the exact cause of damage could not be determined from the photographs.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "during powerglide placement catheter deployed fine but resistance was felt while pulling back to activate safety.Upon removal of needle it was observed that the wire appeared to be short and had sheared off.After further inspection of the device (removing housing to pull wire out and compare wire lengths), it became clear that the safety did not properly deploy and was sitting in front of the needle giving the appearance of a shortened wire.".

• Brand Name: DOT PG PRO 18G 10CM FULL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12582967
• Report Number: 3006260740-2021-04151
• Device Sequence Number: 13763074
• Product Code: FOZ
• UDI-Device Identifier: 00801741110566
• UDI-Public: (01)00801741110566
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• 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): 11/03/2021

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: F118101
• Device Lot Number: REFR1287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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: Male