MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP STRAIGHT 19GX.75" INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 damaged infusions set was confirmed.The product returned for evaluation was two 19ga x 0.75¿ safestep safety infusion sets.Usage residues were observed throughout the samples and the safety mechanisms were engaged.Needleless injection caps were attached to the luer adapters.Partially circumferential splits were observed at the luer/tubing joints.Microscopic inspection of the splits revealed a granular fracture surfaces.Beach marks were observed throughout the fracture surfaces.Material buckling and discoloration were observed in the vicinities of the splits.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, the early signal detection system indicates an additional investigation is necessary.Both bd and the supplier are currently investigating this type of incident and the supplier has been notified of this event.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 that the tubing leaking and then when assessed tubing extending from huber needle noted to be cracked.No other information was provided.Two devices were returned for evaluation.This report addresses the second device.
Additional Manufacturer Narrative
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 damaged infusions set was confirmed.The product returned for evaluation was two 19ga x 0.75¿ safestep safety infusion sets.Usage residues were observed throughout the samples and the safety mechanisms were engaged.Needleless injection caps were attached to the luer adapters.Partially circumferential splits were observed at the luer/tubing joints.Microscopic inspection of the splits revealed a granular fracture surfaces.Beach marks were observed throughout the fracture surfaces.Material buckling and discoloration were observed in the vicinities of the splits.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, the early signal detection system indicates an additional investigation is necessary.Both bd and the supplier are currently investigating this type of incident and the supplier has been notified of this event.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 that the tubing leaking and then when assessed tubing extending from huber needle noted to be cracked.No other information was provided.Two devices were returned for evaluation.This report addresses the second device.

• Brand Name: SAFESTEP STRAIGHT 19GX.75" INFUSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9914228
• Report Number: 3006260740-2020-01097
• Device Sequence Number: 3272203
• Product Code: FPA
• UDI-Device Identifier: 00801741066245
• UDI-Public: (01)00801741066245
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: LH-0033
• Device Lot Number: UNK-F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2243072-06/03/2020-006-R
• Patient Sequence Number: 1
• Patient Age: 2 YR