MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC¿ EZ SAFETY INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that in "the last few weeks there have been repeated extravasation in therapies that were administered by means of an "easypump-system" from fa braun medical ag.The drug is fluoro uracil which is administered 2ml / hour over 48 hours.We were able to determine that 20 g x 25 mm were pierced twice with the needle.We don't know about the others.We could also only observe this during therapy with the pump.I.E.This was not the case with infusion therapy in inpatients.The bandage or fixation was also not the same every time." this report addresses the powerloc ez huber needle used with the "easypump-system".

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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of leaking infusion set is confirmed; however, the exact cause is unknown.One photograph of a powerloc ez infusion set was returned for evaluation.An initial visual observation of the photograph showed a powerloc ez infusion set inserted into the port of a patient.The infusion set is covered by a clear dressing and blood can be seen beneath this dressing.The origin of the blood is unclear from the returned photograph, but the blood residue can be seen on either side of the infusion set base as well as at the location the tubing of the infusion set exits the clear dressing.No splits, holes, or other damage could be seen on the sample in the returned photograph.While the cause of the apparent leak in the infusion set could not be determined from the returned photograph, possible causes include sharp instrument damage, over pressurization, insertion technique, and material fatigue.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that in "the last few weeks there have been repeated extravasation in therapies that were administered by means of an "easypump-system" from fa braun medical ag.The drug is fluoro uracil which is administered 2ml / hour over 48 hours.We were able to determine that 20 g x 25 mm were pierced twice with the needle.We don't know about the others.We could also only observe this during therapy with the pump.I.E.This was not the case with infusion therapy in inpatients.The bandage or fixation was also not the same every time." this report addresses the powerloc ez huber needle used with the "easypump-system.".

• Brand Name: POWERLOC¿ EZ SAFETY INFUSION SET
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12701436
• MDR Text Key: 278534160
• Report Number: 3006260740-2021-04554
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: UNK
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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