MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK MALE EXTERNAL CATHETER KIT

Model Number	PWM030
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the purewick male external catheter was trailed the previous week and a recap call was held with the key decision makers.One of the decision makers made a point to call out the sharp edges in the blue port and stated that this was a patient safety concern.In one instance, the blue port was between a patient's legs and indentions were left.They felt that if it had been left longer it would have caused a pressure injury.To emphasize this concern, they mentioned one of their nurses reported feeling like the blue port cut them when they were connecting it to suction.In fact, it did not cut them but highlighted the sharpness of the port.The affected lots were nggty113 and unk.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿operator error".A device history record review could not be performed as the lot number provided was invalid.A labeling review was not required because a review of the label could not have prevented this issue.H11: section a through f - 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the purewick male external catheter was trialed the previous week and a recap call was held with the key decision makers.One of the decision makers made a point to call out the sharp edges in the blue port and stated that this was a patient safety concern.In one instance, the blue port was between a patient's legs and indentions were left.They felt that if it had been left longer it would have caused a pressure injury.To emphasize this concern, they mentioned one of their nurses reported feeling like the blue port cut them when they were connecting it to suction.In fact, it did not cut them but highlighted the sharpness of the port.The affected lots were nggty113 and unk.

• Brand Name: PUREWICK MALE EXTERNAL CATHETER KIT
• Common Device Name: PUREWICK MALE EXTERNAL CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15371529
• Report Number: 1018233-2022-06975
• Device Sequence Number: 1725941
• Product Code: NZU
• UDI-Device Identifier: 00801741219153
• UDI-Public: (01)00801741219153
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: PWM030
• Device Catalogue Number: PWM030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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