MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML PRECISIONGLIDE SAFETY-LOK SYRINGE; PISTON SYRINGE

Catalog Number	309582
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd 3ml precisionglide¿ safety-lok¿ syringe needle broke off in customers leg.This was discovered during use.The following information was provided by the initial reporter: material no.309582, batch no.3330168.It was reported that needles are breaking off into a customers leg.Received a call about an issue with product 309582.Syringe with hypodermic needle precisionglide¿ 3 ml 25 gauge 1-1/2 inch detachable needle without safety.She said the needles are breaking off in her leg which requires surgery to remove.
Event or Problem Description
It was reported that bd 3ml precisionglide¿ safety-lok¿ syringe needle broke off in customers leg.This was discovered during use.The following information was provided by the initial reporter: material no.309582 batch no.3330168.It was reported that needles are breaking off into a customers leg.Received a call about an issue with product 309582.Syringe with hypodermic needle precisionglide¿ 3 ml 25 gauge 1-1/2 inch.Detachable needle without safety.She said the needles are breaking off in her leg which requires surgery to remove.
Additional Manufacturer Narrative
H.6.Investigation summary: note: batch #3330168 (p/n 309582) expired in 2018.Seventy-one loose 25 gauge 1-1/2 inch needle were received.However, an investigation for this defect is not possible as no guarantees are made regarding product¿s efficacy or function past expiration date.No defects could be confirmed based on the fact the complaint batch was expired.No defects could be confirmed on the received samples because the batch expired in 2018.The batch #3330168 expired in 2018.Investigation, including dhr review, for this defect is not applicable as no guarantees are made regarding product¿s efficacy or function past expiration date.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd 3ml precisionglide¿ safety-lok¿ syringe needle broke off in customers leg.This was discovered during use.The following information was provided by the initial reporter: material no.309582, batch no.3330168.It was reported that needles are breaking off into a customers leg.Received a call about an issue with product 309582.Syringe with hypodermic needle precisionglide¿ 3 ml 25 gauge 1-1/2 inch detachable needle without safety.She said the needles are breaking off in her leg which requires surgery to remove.
Additional Manufacturer Narrative
H.6.Investigation: no samples were received for evaluation.Note: batch #3330168 (p/n 309582) expired in 2018.Investigation for this defect is not possible as no guarantees are made regarding product¿s efficacy or function past expiration date.No defects were confirmed based on the fact that no samples were received and the complaint is for an expired product.H3 other text: see h.10.

• Brand Name: BD 3ML PRECISIONGLIDE SAFETY-LOK SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8843490
• Report Number: 1213809-2019-00784
• Device Sequence Number: 286408
• Product Code: FMF
• UDI-Device Identifier: 30382903095828
• UDI-Public: 30382903095828
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2019

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 Catalogue Number: 309582
• Device Lot Number: 3330168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 07/09/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/05/2019; 11/25/2019
• 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: Required Intervention