MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD HYPO-POSIFLUSH-ANESTHESIA SYRINGE/NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305125
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date : unknown.Medical device lot #: the customer provided lot # 1238429.This does not match the catalog number provided.Initial reporter email address (b) : (b)(6) initial reporter email address (c) : (b)(6) medical device manufacture date : unknown.Investigation summary : exec summary - no physical device samples were returned.As no physical sample, picture sample, or associated lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.No review of the complaint lot history check for leakage was able to be performed on the unknown lot # so the occurrence is unknown, the issue is unconfirmed and root cause can not be determined.Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - no dhr review can be carried out as the lot number is unknown.
Event or Problem Description
It was reported that 3 bd hypo-posiflush-anesthesia syringe/needles leaked.The following information was provided by the initial reporter : the distributor reported a consumer has had a few complaints of their bd needles leaking.Date of event : unknown.
Event or Problem Description
It was reported that 3 bd hypo-posiflush-anesthesia syringe/needles leaked.The following information was provided by the initial reporter : the distributor reported a consumer has had a few complaints of their bd needles leaking.Date of event : unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 01-apr-2022.H6: investigation summary : it was reported the needles are leaking.To aid in the investigation, three samples connected to 3ml syringes were received for evaluation by our quality team.Each sample was connected to a syringe with saline solution and all had leakage from the plastic needle hub.A visual inspection was performed and each needle hub had a hole.The location of the holes measured from the bottom of the needle hub varied.No other defects or imperfections were observed.This defect could occur if there was a jam at the cannulator inducing the damaged.As the lot number provided is 'unknown,' a device history record review could not be completed.Verification of the cannulator was performed.The settings were correct and the flow of products was good.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: BD HYPO-POSIFLUSH-ANESTHESIA SYRINGE/NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13888586
• Report Number: 1911916-2022-00164
• Device Sequence Number: 10990664
• Product Code: FMI
• UDI-Device Identifier: 00382903051250
• UDI-Public: 00382903051250
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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 Catalogue Number: 305125
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown