MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19GX0.75IN WITH Y-SITE; SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported a defective port needles/tubing.The tubing attached to the needle is cracked near the y-site.No other information provided.
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 cracked tubing is inconclusive due to poor sample condition.One photo sample of a 19 ga x 0.75 in powerloc safety infusion set was provided for evaluation.The infusion set is shown besides its packaging.The label information appears to indicate lot: asezf114.The safety mechanism is not activated over the needle bevel and no apparent evidence of use is visible.A red circle is drawn over the y-site luer hub.No apparent damage or deformation could be clearly observed from the image.Based on the description of the reported event, possible contributing factors include damage material fatigue and sharp instrument damage.Since the reported event could not be confirmed from the image provided, the complaint remains inconclusive at this time.A lot history review (lhr) of asezf114 showed no other similar product complaint(s) from this lot number.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported a defective port needles/tubing.The tubing attached to the needle is cracked near the y-site.No other information provided.

• Brand Name: POWERLOC SAFETY INFUSION SET 19GX0.75IN WITH Y-SITE; SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11932584
• Report Number: 3006260740-2021-02144
• Device Sequence Number: 4491272
• Product Code: FPA
• UDI-Device Identifier: 00801741047916
• UDI-Public: (01)00801741047916
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 0671934
• Device Lot Number: ASEZF114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other