MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE NEEDLE; PISTON SYRINGE

Catalog Number	305905
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: hypodermic single lumen needle, medical device type: fmi.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987 (syringe), pma / 510(k)#: k951254 (needle).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter was found in the bd safetyglide¿ needle after unpacking it.The following information was provided by the initial reporter, translated from chinese to english: "unpacking and finding that the space is dirty".
Event or Problem Description
It was reported that foreign matter was found in the bd safetyglide¿ needle after unpacking it.The following information was provided by the initial reporter, translated from chinese to english: "unpacking and finding that the space is dirty".
Additional Manufacturer Narrative
H6: investigation summary: one photo was received showing a loose safetyglide needle (p/n 305905).The photo was visually evaluated.The needle shield appeared to be covered in a gray foreign matter amount observed was rejectable per product specification.It was not able to be determined from the photo if the foreign matter was embedded or loose.A physical sample is necessary to perform a more complete evaluation.A physical sample is required for a more thorough evaluation and potential root cause determination.Since root cause could not be defined, corrective actions are not necessary at this time.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.

• Brand Name: BD SAFETYGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11815472
• Report Number: 1213809-2021-00307
• Device Sequence Number: 19810956
• Product Code: FMF
• UDI-Device Identifier: 00382903059058
• UDI-Public: 00382903059058
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 305905
• Device Lot Number: 0317427
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1