MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PRECISIONGLIDE SYRINGE ALLERGY 1ML W/ NEEDLE 28X1/2 RB; ALLERGY SYRINGE & NEEDLE

Catalog Number	305500
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd precisionglide¿ syringe allergy 1 ml w/ needle 28x1/2 rb penetrated through shield and caused a needle stick injury.The following information was provided by the initial reporter: material no: 305500.Batch no: unknown.It was reported that the syringe needle stuck her finger as she was preparing for her injection she is concerned that the needle may cause an infection.Verbatim: consumer reported that the syringe needle stuck her finger as she was preparing for her injection.She stated that she took the syringe out of the bag and put it on the counter and when she picked it up she was stuck with the needle that was bent through the shield.Consumer did not seek medical attention but she is concerned that the needle may cause an infection.She will contact us with any updates if she goes to the doctor.Problem occurred on (b)(6) 2019, lot # is unavailable, product # 305500, no exp date.Consumer will send sample and poly bag.
Additional Manufacturer Narrative
The following fields have been updated with corrections: g.5.Pma/510(k)#: k980580, k941657.
Event or Problem Description
It was reported that bd precisionglide¿ syringe allergy 1ml w/ needle 28x1/2 rb penetrated through shield and caused a needle stick injury.The following information was provided by the initial reporter: material no: 305500 batch no: unknown it was reported that the syringe needle stuck her finger as she was preparing for her injection she is concerned that the needle may cause an infection.Verbatim: consumer reported that the syringe needle stuck her finger as she was preparing for her injection.She stated that she took the syringe out of the bag and put it on the counter and when she picked it up she was stuck with the needle that was bent through the shield.Consumer did not seek medical attention but she is concerned that the needle may cause an infection.She will contact us with any updates if she goes to the doctor.Problem occurred on (b)(6) 2019, lot # is unavailable, product # 305500, no exp date.Consumer will send sample and poly bag.
Additional Manufacturer Narrative
Investigation summary: customer returned (4) 1cc, 12.7mm, 28g bd allergy syringes in an open poly bag with a worn out, illegible lot number.Customer states that she was stuck with the needle that was bent through the shield.All returned syringes were examined and one syringe exhibited a bent cannula and a hole in the shield.This indicates that the cannula was through the shield, exposing the cannula, which could lead to a needle stick.A dhr check was not performed as the lot number is "unknown" for this complaint.Based on the samples and/or photo(s) received the investigation concluded: -confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.As per manufacturing, "probable root cause for the damage to the barrel is from the exposed cannula on the syringe getting caught in the web material during the form, fill, and seal process.The barrel of the syringe would have been caught in the jaws that seal the polybag.Probable root cause for the cannula pierced through the shield is a misalignment during the shielding process at the pils.Capa 529089 for needle through shield on allergy syringes was implemented on (b)(6) 2019 which is after the date of manufacture that is marked on the polybag." 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 precisionglide¿ syringe allergy 1ml w/ needle 28x1/2 rb penetrated through shield and caused a needle stick injury.The following information was provided by the initial reporter: material no: 305500 batch no: unknown it was reported that the syringe needle stuck her finger as she was preparing for her injection she is concerned that the needle may cause an infection.Verbatim: consumer reported that the syringe needle stuck her finger as she was preparing for her injection.She stated that she took the syringe out of the bag and put it on the counter and when she picked it up she was stuck with the needle that was bent through the shield.Consumer did not seek medical attention but she is concerned that the needle may cause an infection.She will contact us with any updates if she goes to the doctor.Problem occurred on (b)(6) 2019, lot # is unavailable, product # 305500, no exp date.Consumer will send sample and poly bag.

• Brand Name: BD PRECISIONGLIDE SYRINGE ALLERGY 1ML W/ NEEDLE 28X1/2 RB
• Common Device Name: ALLERGY SYRINGE & NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8660565
• Report Number: 1920898-2019-00503
• Device Sequence Number: 11295356
• Product Code: FMF
• UDI-Device Identifier: 30382903055006
• UDI-Public: 30382903055006
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• 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): 06/25/2019

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: 305500
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 05/13/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/04/2019; 06/25/2019
• 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: Other