MAUDE Adverse Event Report: ALLPOINTS PORT ACCESS SYSTEM 20 G X 0.75 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reex2518 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reex2518) have been reported from the same facility.
Event or Problem Description
It was reported "we have a 3 year old that now has had 2 tubing fractures with the power needle in the all points kits and unfortunately he has a confirmed clabsi.Rl¿s have been placed and one of the needles was sent to value analysis." this report addresses the device that was saved and sent to value analysis.
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, 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 a damaged infusion set was confirmed.The product returned for evaluation was one 20ga x 0.75¿ powerloc max safety infusion set.Usage residues were observed throughout the sample.A needleless injection cap was attached to the luer adapter and the safety mechanism was engaged.A partially circumferential split was observed at the luer/tubing joint.Microscopic inspection of the split revealed a granular fracture surface.Beach marks and radiating tear marks were observed throughout the fracture surface.Material buckling and discoloration were observed in the vicinity of the split.The split characteristics and material buckling were consistent with material failure due to repetitive stress.It appeared that the tubing fractured, in part, due to repetitive torsional (twisting) stress, suggesting that securement, access and maintenance techniques may have contributed; however, it appeared that an additional unidentified factor(s) may have contributed.The supplier has been notified of this even.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "we have a 3 year old that now has had 2 tubing fractures with the power needle in the all points kits and unfortunately he has a confirmed clabsi.Rl¿s have been placed and one of the needles was sent to value analysis." this report addresses the device that was saved and sent to value analysis.

• Brand Name: ALLPOINTS PORT ACCESS SYSTEM 20 G X 0.75 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12181022
• Report Number: 3006260740-2021-02771
• Device Sequence Number: 2825974
• Product Code: FPA
• UDI-Device Identifier: 00801741118272
• UDI-Public: (01)00801741118272
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• 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): 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AS142075
• Device Lot Number: REEX2518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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: Required Intervention
• Patient Age: 3 YR