MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asezf908 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when using the set for infusion, blue extraneous matters were found in the extension tubing.Infusion was discontinued immediately and the infusion set was replaced.

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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of blue material within the infusion set extension tubing was confirmed; however, the root cause was not identified.The product returned for evaluation was one 20ga x 0.75¿ powerloc safety infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged.A non-vad 3-way valve was attached to the luer adapter.Blue material was observed within the infusion set extension tubing and within the 3-way valve.Microscopic inspection of the blue material revealed that it appeared comprised of plastic.The material fragments exhibited deformation and discoloration.The fragments were larger than the inner diameter of the needle shaft.A review of the infusion set manufacturing processes did not reveal any potential sources of the observed material.Both the locations of the material and the size suggested that the material was introduced to the infusion set externally; however, the source of the material was not identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that when using the set for infusion, blue extraneous matters were found in the extension tubing.Infusion was discontinued immediately and the infusion set was replaced.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN
• Type of Device: 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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12796778
• MDR Text Key: 280703037
• Report Number: 3006260740-2021-04790
• 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: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 8652034
• Device Lot Number: ASEZF908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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