MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL; PISTON SYRINGE

Catalog Number	305064
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: 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 an unspecified number of syr 10ml ll w/ndl 18x1-1/2 blunt fill caused a serious injury in the form of a change in the course of treatment which was determined necessary prior to use.The following information was provided by the initial reporter: in preparation for performing spinal anesthesia in the patient it was found that the needle was without the stylet, and it is not possible to use the material, we need to interrupt the procedure to find another material, delaying the beginning of surgery.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples displaying the condition reported are available for examination.We were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, 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 section h.10.
Event or Problem Description
It was reported that an unspecified number of syr 10ml ll w/ndl 18x1-1/2 blunt fill caused a serious injury in the form of a change in the course of treatment which was determined necessary prior to use.The following information was provided by the initial reporter: in preparation for performing spinal anesthesia in the patient it was found that the needle was without the stylet, and it is not possible to use the material, we need to interrupt the procedure to find another material, delaying the beginning of surgery.

• Brand Name: SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8875000
• Report Number: 1213809-2019-00810
• Device Sequence Number: 2755361
• Product Code: FMF
• UDI-Device Identifier: 30382903050643
• UDI-Public: 30382903050643
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 305064
• Device Lot Number: 8010903
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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