MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP NEEDLE 22G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	LH-0030YN
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asens0040 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported that needle is not in the needle cover.No other information was provided.
Event or Problem Description
It was reported that needle is not in the needle cover.No other information was 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, complaint and lot history review, 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 an exposed needle is confirmed and was determined to be supplier related.One 22 g x 1 in.Safestep infusion set with a valved y-site was returned for evaluation.An initial visual observation showed the package was returned sealed and it was observed that the needle of the infusion set was protruding from the side of the needle guard near the center of the guard.Multiple holes were observed in the packaging where the exposed needle had pierced it.The cause of this condition is most likely misassembly of the needle guard during product assembly at the supplier facility.H3 other text: evaluation findings are in section h11.

• Brand Name: SAFESTEP NEEDLE 22G X 1 IN WITH Y-SITE
• 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: 10995384
• Report Number: 3006260740-2020-20863
• Device Sequence Number: 11437922
• Product Code: FPA
• UDI-Device Identifier: 00801741066191
• UDI-Public: (01)00801741066191
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: Other
• Device Model Number: LH-0030YN
• Device Catalogue Number: LH-0030YN
• Device Lot Number: ASENS0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 02/28/2021
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 03/25/2021
• 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