MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  malfunction  

Event Description

It was reported outer packing damaged.No other information was provided.

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 manufacturer has received the sample and will evaluate.Results are expected soon.

Event Description

It was reported outer packing damaged.No other information was provided.

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 complaint of an open seal on the package was confirmed but the cause is unknown.A series of two photographs were returned for evaluation of this complaint.The photographs showed a powerloc infusion set in its packaging.One of the photographs was of the film side of the packaging containing the non-english label.The label was printed with the product number 8652034 and the lot number asgpf909.The label obscured the damaged section of the seal, so it could not be determined if the seal width was consistent on the packaging.The second photograph showed the section of the packaging seal that was open.The opened section of the seal was located on the side of the pouch.It appeared that there may have been a small section of plastic tearing at the terminating end of the open seal, which may indicate that the package had been sealed initially.However, this could not be confirmed without examination of the physical sample.The submitted photographs did not contain enough information to identify a specific root cause for the open seal.Possible contributing factors could include seal damage during shipping or storage, or inadvertent damage to the seal by the user prior to use.The report of an open packaging seal has been documented and included in complaint trending.This type of complaint will continue to be monitored as part of ongoing efforts to identify potential issues.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17035347
• MDR Text Key: 316295150
• Report Number: 3006260740-2023-02171
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741048333
• UDI-Public: (01)00801741048333
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 8652034
• Device Lot Number: ASGPF909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other