MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 19G X 0.75IN; 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	02/18/2021
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) of asexf021 showed four other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported patient was sent home on chemotherapy via an infusion pump.When they came back to the clinic 96 hours for a bag change, leaking was noted with the bd/bard port access needle.Additional information provided 02/23/2021: "the break occurred where the tubing is attached to the actual entire port, not something the nurses are putting on." pediatric oncology patient were receiving a: 28 day infusion; pediatric oncology patient had bag of drug changed every 72-96 hours (where leaking is being reported by parent or clinician); administered blinatumumab (brand blincyto); patient sent home with the infusion through a cadd (smith medical) home infusion pump; and leaking was reported where the tubing meets the hub where above a needleless connector/cstd would be connected.
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 19ga x 0.75¿ safestep safety infusion set.Usage residues were observed throughout the sample and a needleless injection cap was attached to the luer adapter.A partially circumferential split was observed at the proximal luer/tubing joint.Microscopic inspection of the split revealed a granular fracture surface.Beach 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.
Event or Problem Description
It was reported patient was sent home on chemotherapy via a infusion pump.When they came back to the clinic 96 hours for a bag change, leaking was noted with the bd/bard port access needle.Additional information provided 02/23/2021: ".The break occurred where the tubing is attached to the actual entire port, not something the nurses are putting on." pediatric oncology patient were receiving a: 28 day infusion, pediatric oncology patient had bag of drug changed every 72-96 hours (where leaking is being reported by parent or clinician), administered blinatumumab (brand blincyto), patient sent home with the infusion through a cadd (smith medical) home infusion pump, leaking was reported where the tubing meets the hub where above a needleless connector/cstd would be connected.

• Brand Name: SAFESTEP HUBER NEEDLE SET 19G X 0.75IN
• 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: 11473148
• Report Number: 3006260740-2021-00787
• Device Sequence Number: 11616129
• Product Code: FPA
• UDI-Device Identifier: 00801741066245
• UDI-Public: (01)00801741066245
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: LH-0033
• Device Lot Number: ASEXF021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/09/2021
• 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