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
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
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 aseps0010 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "when deaccessing a port-a-cath, the port needle did not retract into the safety.The needle had to be physically pulled out of the port and the safety was not able to be applied." placement info: port a cath single lumen-right internal jugular no harm to patient.
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 cracked infusion set y-site luer was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was two 20ga x 0.75¿ powerloc max safety infusion sets with y-site.The first sample (sample 1) exhibited usage residues throughout.Needleless injection caps were attached to both luer adapters.A longitudinally aligned split was observed in the y-site, extending from the orifice past the attached accessory.Microscopic inspection of sample 1 revealed that the split occurred along a molding weld line.The split surfaces were dull and granular.Sample 2 was received in its original sealed packaging.The sample was unused.Microscopic inspection of sample 2 confirmed a molding weld line in the y-site but was otherwise unremarkable.The crack occurred along a feature caused during the molding process.The device is a supplied component and corrective actions have been implemented by the supplier.The complaint sample was manufactured prior to implementation of those actions.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported via medwatch "when deaccessioning a port-a-cath, the port needle did not retract into the safety.The needle had to be physically pulled out of the port and the safety was not able to be applied." placement info: port a cath single lumen-right internal jugular no harm to patient.

• 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: 10714389
• Report Number: 3006260740-2020-20208
• Device Sequence Number: 17067299
• Product Code: FPA
• UDI-Device Identifier: 00801741066245
• UDI-Public: (01)00801741066245
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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 Expiration Date: 01/28/2023
• Device Model Number: N/A
• Device Catalogue Number: LH-0033
• Device Lot Number: ASEPS0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 12/30/2020
• 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